meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
42
Latest Decision
1989-04-14

Clearances · page 25 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K892125 EZ COMPLEMENT C2 Diamedix Corp. CZW Class II 1989-04-14
K892129 EZ COMPLEMENT C4 Diamedix Corp. DBI Class II 1989-04-14
K891683 TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER Helena Laboratories CZN Class II 1989-04-12
K890530 N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) Behring Diagnostics, Inc. DGC Class II 1989-03-27
K891299 MID-LEVEL IGG KIT CAT. NO. 9315 Helena Laboratories DAQ Class I 1989-03-22
K891188 TITAN GEL IFE TRIVALENT ANTISERUM Helena Laboratories CFQ Class II 1989-03-22
K891098 ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) Immco Diagnostics, Inc. DBL Class II 1989-03-22
K891099 ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) Immco Diagnostics, Inc. DBL Class II 1989-03-22
K890991 MONO-CUBE(TM) Difco Laboratories, Inc. KTN Class II 1989-03-16
K890694 BETA-2 MICROGLOBULIN EIA Serex, Inc. JZG Class II 1989-03-16
K890697 RIA-GNOST FERRITIN Cambridge Medical Technology JMG Class II 1989-03-16
K890421 IMX B2-MICROGLOBULIN Abbott Laboratories JZG Class II 1989-03-09
K885307 FLIPSCREEN (TM) TOTAL E IMMUNOASSAY Alerchek, Inc. DGC Class II 1989-03-08
K890675 THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 Unipath , Ltd. CZW Class II 1989-03-06
K890563 SPQ(TM) ANTIBODY REAGENT SET II FOR TRF Atlantic Antibodies DDG Class II 1989-03-03
K890561 SPQ(TM) ANTIBODY REAGENT SET II FOR IGM Atlantic Antibodies CFQ Class II 1989-02-23
K890562 SPQ(TM) ANTIBODY REAGENT SET II FOR HPT Atlantic Antibodies DAD Class II 1989-02-22
K890416 SPQ(TM) ANTIBODY REAGENT SET II FOR IGG Atlantic Antibodies DEW Class II 1989-02-22
K884501 QUIDEL FOOD ALLERGY SCREEN Quidel Corp. DHB Class II 1989-02-17
K890417 SPQ(TM) ANTIBODY REAGENT SET II FOR C3 Atlantic Antibodies KTQ Class I 1989-02-17
K890564 SPQ(TM) ANTIBODY REAGENT SET II FOR C4 Atlantic Antibodies DBI Class II 1989-02-17
K890415 SPQ(TM) ANTIBODY REAGENT SET II FOR AAT Atlantic Antibodies DEM Class II 1989-02-17
K890423 V-TREND TARGET CRP TEST Texas Immunology, Inc. DCK Class II 1989-02-17
K890560 SPQ(TM) ANTIBODY REAGENT SET II FOR IGA Atlantic Antibodies CZP Class II 1989-02-15
K885269 ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS Dexall Biomedical Labs, Inc. DHB Class II 1989-02-07
K884180 TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM Unipath , Ltd. DHR Class II 1989-02-03
K885048 ACCESS R-CLONE ANA PROFILE ASSAY Lipogen, Inc. DHC Class II 1989-01-24
K884883 28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM) Diagnostic Products Corp. DHB Class II 1989-01-23
K890041 V-TREND TARGET IM TEST Texas Immunology, Inc. KTN Class II 1989-01-23
K884923 MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM) Diagnostic Products Corp. DHB Class II 1989-01-11
K884766 BERICHROM(R) PLASMINOGEN Behring Diagnostics, Inc. DDX Class I 1989-01-04
K885065 IGE FASTSCREEN S6 (F1, F2, F4, F13, F14) 3M Company DHB Class II 1989-01-04
K885074 AFFINITY(TM) FERRITIN IMMUNIT(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic DBF Class II 1989-01-04
K884683 FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. DBF Class II 1988-12-27
K883709 MODIFICATION OF MONO-PLUS(TM) Armkel, LLC KTN Class II 1988-12-20
K885001 QM300 PCR ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DCN Class II 1988-12-20
K884597 BECKMAN LAMBDA LIGHT CHAIN REAGENT Beckman Instruments, Inc. DFH Class II 1988-12-06
K884007 CARDS(TM) MONO Pacific Biotech, Inc. KTN Class II 1988-11-18
K884276 BECKMAN KAPPA LIGHT CHAIN REAGENT Beckman Instruments, Inc. DFH Class II 1988-11-16
K884496 RIA/MAT FPA TEST KIT Altana, Inc. DAN Class II 1988-11-16
K884545 DELFIA (TM) HIGE KIT Pharmacia, Inc. DGC Class II 1988-11-10
K884217 TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN Technicon Instruments Corp. LKL Class I 1988-11-04
K884400 ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) Immco Diagnostics, Inc. DHN Class II 1988-11-04
K883537 QM300 CONTROL E Kallestad Diag, A Div. of Erbamont, Inc. DHB Class II 1988-11-04
K884298 SPQ(TM) TEST SYSTEM FOR MICROALBUMIN Atlantic Antibodies JZJ Class I 1988-11-02
K884297 SPQ(TM) TEST SYSTEM FOR PREALBUMIN Atlantic Antibodies JZJ Class I 1988-11-02
K884147 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M Orion Diagnostica, Inc. DFT Class II 1988-10-27
K884185 CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY Ciba Corning Diagnostics Corp. DHB Class II 1988-10-27
K883371 MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) 3M Company DHB Class II 1988-10-27
K883949 ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) Immco Diagnostics, Inc. LKJ Class II 1988-10-27
K883883 ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) Immco Diagnostics, Inc. LKJ Class II 1988-10-27
K884074 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G Orion Diagnostica, Inc. DAH Class II 1988-10-27
K883746 MICROMEDIC FERRITIN IRMA KIT Icn Micromedic Systems DBF Class II 1988-10-27
K883540 OXOID INFECTIOUS MONONUCLEOSIS KIT Unipath , Ltd. KTN Class II 1988-10-19
K883915 AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) Immco Diagnostics, Inc. DBL Class II 1988-10-19
K884101 DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. DCK Class II 1988-10-19
K884075 IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN Orion Diagnostica, Inc. DDG Class II 1988-10-19
K884040 IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A Orion Diagnostica, Inc. CZP Class II 1988-10-19
K883666 QUIDEL ALLERGY SCREEN Quidel Corp. DHB Class II 1988-10-18
K881259 MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL Triton Biosciences, Inc. LYE Class II 1988-10-12
K883712 QM300 CONTROL F PACK Kallestad Diag, A Div. of Erbamont, Inc. DFC Class II 1988-09-22
K883493 TECHNICON DPA-1 IMMUNOGLOBULIN M Technicon Instruments Corp. DFL Class II 1988-09-22
K881341 NOVA LITE(TM) SA Inova Diagnostics, Inc. LLL Class II 1988-09-22
K883515 DU PONT DIMENSION C-REACTIVE PROTEIN METHOD E.I. Dupont DE Nemours & Co., Inc. DCN Class II 1988-09-22
K883001 QM300 CALIBRATOR D PACK Kallestad Diag, A Div. of Erbamont, Inc. CZJ Class II 1988-09-22
K883711 QM300 CALIBRATOR F PACK Kallestad Diag, A Div. of Erbamont, Inc. DFC Class II 1988-09-22
K883492 TECHNICON DPA-1 IMMUNOGLOBULIN A Technicon Instruments Corp. CZP Class II 1988-09-22
K882740 ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY Lipogen, Inc. LKJ Class II 1988-09-22
K883616 SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) Diagnostic Products Corp. DHB Class II 1988-09-22
K883002 QM300 PREALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. JZJ Class I 1988-09-22
K883349 QLIA IMMUNOCHEMISTRY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JZT Class I 1988-09-07
K883355 UBI MAGIWEL RF-IGM QUANTITATIVE United Biotech, Inc. DHR Class II 1988-09-07
K883273 DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) 3M Company DHB Class II 1988-09-07
K883232 HISTONE REACTIVE ANA Val Tech Diagnostics, Inc. LLL Class II 1988-09-07
K883538 QM300 CALIBRATOR E PACK Kallestad Diag, A Div. of Erbamont, Inc. DHR Class II 1988-09-07
K882998 ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST Amtec Diagnostics International, Inc. DCK Class II 1988-09-07
K883494 TECHNICON DPA-1 IMMUNOGLOBULIN G Technicon Instruments Corp. DAH Class II 1988-09-07
K883536 QM300 RHEUMATOID FACTOR ANTIGEN PACK Kallestad Diag, A Div. of Erbamont, Inc. DHR Class II 1988-09-07
K881899 SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. Diagnostic Products Corp. DHB Class II 1988-08-10
K882625 PHARMACIA IGE RIA ULTRA Pharmacia, Inc. DGC Class II 1988-08-08
K882822 FIAGEN FERRITIN Cyberfluor, Inc. DFL Class II 1988-08-04
K882616 ALTERNATE PROCEDURE, PHARMACIA IGE EIA Pharmacia, Inc. JHR Class II 1988-08-04
K882626 PHARMACIA IGE EIA ULTRA Pharmacia, Inc. DGC Class II 1988-08-04
K882153 TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. DCF Class II 1988-08-04
K883004 MONO-PLUS(TM) Wampole Laboratories KTN Class II 1988-08-04
K882829 CIRCULATING IMMUNE COMPLEXES CONTROLS Cytotech, Inc. DAK Class II 1988-08-04
K882677 STAT-20 FLUOROMETER Weaver Medical JZT Class I 1988-07-12
K882369 ACCRAASSAY RID KITS Icn Immunobiologicals DEW Class II 1988-07-12
K881928 MONOCLONAL RADIAL IMMUNODIFFUSION KIT The Binding Site, Ltd. CFQ Class II 1988-07-08
K882082 QM300 ALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DCF Class II 1988-07-08
K882446 ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. DEM Class II 1988-07-08
K882374 WAKO(TM) CRP Wako Chemicals USA, Inc. DCN Class II 1988-07-08
K882621 COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. DBI Class II 1988-07-08
K882083 QM300 IGG ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DEW Class II 1988-07-08
K882623 PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. JZH Class II 1988-07-08
K882622 CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. JFR Class II 1988-07-08
K864893 ANTI-CYTOKERATIN MONOCLONAL ANTIBODY Bd Becton Dickinson Vacutainer Systems Preanalytic LYE Class II 1988-07-07
K875110 HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC Incstar Corp. DHB Class II 1988-06-14
K881827 IMMUNOGLOBULIN A TEST SYSTEM The Binding Site, Ltd. CFQ Class II 1988-06-10
K881892 PHARMACIA IGE RIACT Pharmacia, Inc. DGC Class II 1988-06-10

3,548 clearances in the Immunology panel. Data: openFDA.