FDA Product Code
FDA Product Code DHB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5750
510(k) Clearances — 269 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | 2026-09-04 | Traditional | PDF ↗ |
| K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut | Hycor Biomedical | 2026-07-24 | Traditional | PDF ↗ |
| K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut | Hycor Biomedical | 2026-07-21 | Traditional | PDF ↗ |
| K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical | 2026-06-18 | Traditional | PDF ↗ |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | Hycor Biomedical | 2026-05-15 | Traditional | PDF ↗ |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | Hycor Biomedical | 2026-01-16 | Traditional | PDF ↗ |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical | 2025-12-23 | Traditional | PDF ↗ |
| K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz | Hycor Biomedical | 2025-04-23 | Traditional | PDF ↗ |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed | Phadia AB | 2022-08-03 | Traditional | PDF ↗ |
| K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria | Hycor Biomedical | 2022-02-18 | Traditional | PDF ↗ |
| K193613 | Allergen-Specific IgE Assay 12 Allergen Bundle | Hitachi Chemical Diagnostics, Inc. | 2021-10-18 | Traditional | PDF ↗ |
| K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense | Hycor Biomedical | 2020-06-26 | Traditional | PDF ↗ |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine | Phadia AB | 2020-05-01 | Traditional | PDF ↗ |
| K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae | Hycor Biomedical | 2019-07-31 | Traditional | PDF ↗ |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat | Phadia AB | 2019-05-14 | Traditional | PDF ↗ |
| K182793 | AP3600 Automated Instrument | Hitachi Chemical Diagnostics, Inc. | 2019-03-19 | Traditional | PDF ↗ |
| K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus | Hycor Biomedical | 2018-12-04 | Traditional | PDF ↗ |
| K173726 | ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | Phadia AB | 2018-04-16 | Traditional | PDF ↗ |
| K163370 | ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE | Phadia AB | 2017-05-05 | Traditional | PDF ↗ |
| K150597 | ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite | Phadia AB | 2016-02-29 | Traditional | PDF ↗ |
| K151029 | Phadia Prime | Phadia AB | 2016-01-19 | Special | PDF ↗ |
| K150854 | ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut | Phadia AB | 2015-12-14 | Traditional | PDF ↗ |
| K132801 | IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY | Siemens Healthcare Diagnostics, Inc. | 2014-05-28 | Traditional | PDF ↗ |
| K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | Phadia US, Inc. | 2013-08-28 | Traditional | PDF ↗ |
| K131738 | IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H | Phadia AB | 2013-07-10 | Special | PDF ↗ |
| K123275 | IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM | Phadia AB | 2013-06-28 | Traditional | PDF ↗ |
| K121156 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | Phadia AB | 2013-03-13 | Traditional | PDF ↗ |
| K121463 | IMMUNOCAP ALLERGEN K82 | Thermo Fisher Scientific | 2013-01-29 | Traditional | PDF ↗ |
| K112910 | AP 72OS SEMI-AUTOMATED INSTRUMENT | Hitachi Chemical Diagnostics, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | Phadia US, Inc. | 2012-09-13 | Traditional | PDF ↗ |
| K112523 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics, Inc. | 2012-01-06 | Traditional | PDF ↗ |
| K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | Phadia US, Inc. | 2011-12-22 | Traditional | PDF ↗ |
| K101572 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | 2011-08-01 | Traditional | PDF ↗ |
| K101251 | IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN | Phadia AB | 2011-05-27 | Traditional | PDF ↗ |
| K100910 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | Siemens Medical Solutions Diagnostics | 2011-05-11 | Traditional | PDF ↗ |
| K093987 | IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 | Siemens Healthcare Diagnostics, Inc. | 2011-03-28 | Traditional | PDF ↗ |
| K100999 | IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 | Phadia AB | 2010-12-15 | Traditional | PDF ↗ |
| K093107 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | 2010-09-30 | Traditional | PDF ↗ |
| K092978 | IMMUNOCAP RAPID READER, MODEL 12-3600-10 | Phadia US, Inc. | 2010-01-19 | Traditional | PDF ↗ |
| K092050 | IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 | Phadia AB | 2009-11-20 | Traditional | PDF ↗ |
| K091984 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | Siemens Medical Solutions Diagnostics | 2009-10-28 | Traditional | PDF ↗ |
| K091289 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | 2009-08-06 | Traditional | PDF ↗ |
| K090257 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | 2009-05-26 | Traditional | PDF ↗ |
| K083853 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | 2009-03-24 | Traditional | PDF ↗ |
| K081830 | IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 | Phadia AB | 2009-03-16 | Traditional | PDF ↗ |
| K083314 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT | Siemens Healthcare Diagnostics | 2009-03-11 | Traditional | PDF ↗ |
| K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | Hycor Biomedical, Inc. | 2008-05-22 | Special | PDF ↗ |
| K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 | Hycor Biomedical, Inc. | 2008-03-05 | Special | PDF ↗ |
| K071913 | IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 | Phadia AB | 2007-08-24 | Traditional | PDF ↗ |
| K051677 | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY | Hitachi Chemical Diagnostics, Inc. | 2006-01-23 | Traditional | PDF ↗ |
| K051218 | MODIFICATION TO: UNICAP SPECIFIC IGE | Pharmacia Diagnostics AB | 2005-06-09 | Special | PDF ↗ |
| K030590 | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) | Hitachi Chemical Diagnostics, Inc. | 2003-03-21 | Special | PDF ↗ |
| K023152 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE | Diagnostic Products Corp. | 2002-12-17 | Abbreviated | PDF ↗ |
| K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS | Diagnostic Products Corp. | 2002-05-30 | Traditional | PDF ↗ |
| K021206 | IMMULITE 2000 SPECIFIC ALLERGENS | Diagnostic Products Corp. | 2002-05-30 | Traditional | PDF ↗ |
| K020387 | MYALLERGYTEST SYSTEM | Immunetech Corporation | 2002-04-17 | Traditional | PDF ↗ |
| K013135 | IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) | Diagnostic Products Corp. | 2001-10-19 | Special | PDF ↗ |
| K013134 | IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) | Diagnostic Products Corp. | 2001-10-15 | Special | PDF ↗ |
| K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 | Pharmacia & Upjohn Co. | 2000-02-18 | Traditional | PDF ↗ |
| K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F | Pharmacia & Upjohn Co. | 1999-12-01 | Traditional | PDF ↗ |
| K991048 | ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 | Pharmacia & Upjohn Co. | 1999-05-14 | Traditional | PDF ↗ |
| K983954 | ALASTAT MICROPLATE MIXED ALLERGEN PANELS | Diagnostic Products Corp. | 1998-12-17 | Traditional | PDF ↗ |
| K982343 | ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 | Pharmacia & Upjohn Co. | 1998-09-15 | Traditional | PDF ↗ |
| K974580 | ALLERGEN IMMUNOCAP F256,F245,F207,F202 | Pharmacia & Upjohn Co. | 1998-02-09 | Traditional | PDF ↗ |
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Pharmacia, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K973186 | IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE | Diagnostic Products Corp. | 1997-09-29 | Traditional | PDF ↗ |
| K972364 | UNICAP PHADIATOP | Pharmacia, Inc. | 1997-09-04 | Traditional | PDF ↗ |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | Pharmacia, Inc. | 1997-07-03 | Traditional | PDF ↗ |
| K965094 | HYCOR ALLERGEN DISC | Hycor Biomedical, Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K962976 | PHARMACIA CAP SYSTEM RAST FEIA | Pharmacia & Upjohn Co. | 1996-12-23 | Traditional | PDF ↗ |
| K963245 | IMMULITE LATEX-SPECIFIC IGE | Diagnostic Products Corp. | 1996-11-18 | Traditional | PDF ↗ |
| K961889 | SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS | Diagnostic Products Corp. | 1996-10-10 | Traditional | PDF ↗ |
| K962274 | UNICAP 100 | Pharmacia, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Pharmacia, Inc. | 1996-01-30 | Traditional | PDF ↗ |
| K954566 | SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM | Diagnostic Products Corp. | 1995-12-18 | Traditional | PDF ↗ |
| K953780 | ACCESS ALLERGEN DOG EPITHELIM | Bio-Rad Laboratories, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K950728 | QUICKVUE ONE-STEP ALLERGEN SCREEN | Quidel Corp. | 1995-10-02 | Traditional | PDF ↗ |
| K953014 | ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN | Diagnostic Products Corp. | 1995-08-15 | Traditional | PDF ↗ |
| K945884 | SPECIFIC IGE ULTRA-EIA | Hycor Biomedical, Inc. | 1995-06-30 | Traditional | PDF ↗ |
| K945748 | HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY | Hycor Biomedical, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K950629 | ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR | Bio-Rad Laboratories, Inc. | 1995-05-23 | Traditional | PDF ↗ |
| K931746 | LATEX (K82) | Diagnostic Products Corp. | 1995-03-21 | Traditional | PDF ↗ |
| K941278 | HY-TEC AUTOMATED EIA SYSTEM | Hycor Biomedical, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K943768 | HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT | Diagnostic Products Corp. | 1995-03-06 | Traditional | PDF ↗ |
| K941057 | SPECIFIC IGE EIA-ULTRA ASSAY | Hycor Biomedical, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K941564 | IMMULITE ALATOP ALLERGY SCREEN | Diagnostic Products Corp. | 1994-12-19 | Traditional | PDF ↗ |
| K935488 | ALATOP(R) MICROPLATE ALLERGY SCREEN | Diagnostic Products Corp. | 1994-03-22 | Traditional | PDF ↗ |
| K935876 | ACCESS SPECIFIC IGE ASSAY | Bio-Rad Laboratories, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K926420 | MAST CLA ALLERGY SYSTEM | Mast Immunosystems | 1994-03-07 | Traditional | PDF ↗ |
| K934524 | MAST CLA ALLERGY SYSTEM | Mast Immunosystems | 1994-03-07 | Traditional | PDF ↗ |
| K925044 | VENTREX ALLERGEN DISC | Ventrex, Inc. | 1993-05-14 | Traditional | PDF ↗ |
| K923420 | CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY | Ciba Corning Diagnostics Corp. | 1993-02-23 | Traditional | PDF ↗ |
| K925425 | SPECIFIC IGE EIA-TURBO ASSAY | Hycor Biomedical, Inc. | 1993-01-14 | Traditional | PDF ↗ |
| K924044 | VENTREX ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K924209 | VENTREX ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-11-30 | Traditional | PDF ↗ |
| K924119 | VENTREX ALLERGEN DISC | Ventrex, Inc. | 1992-11-30 | Traditional | PDF ↗ |
| K923284 | BASELINE CALIBRATION VERIFICATION CONTROLS | Hycor Biomedical, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K914685 | 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS | In Vitro Technologies, Inc. | 1992-09-14 | Traditional | PDF ↗ |
| K914959 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1992-08-20 | Traditional | PDF ↗ |
| K921574 | WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-08-03 | Traditional | PDF ↗ |
Product code DHB · Class II · Immunology. Data: openFDA.