meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
35
Latest Decision
1986-12-22

Clearances · page 28 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K863967 SPECIFIC IGE FAST(TM) TEST II 3M Company DHB Class II 1986-12-22
K863743 BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT Immuno Nuclear Corp. DHB Class II 1986-12-15
K864275 ANTI-NDNA ANTIBODY TEST KIT Cappel Diagnostics, Inc. KTL Class II 1986-12-15
K864212 IL TEST 97573-15, PLASMINOGEN ASSAY Instrumentation Laboratory CO DDX Class I 1986-12-04
K864142 UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE United Biotech, Inc. DGC Class II 1986-12-03
K863327 IMMPULSE IGE ASSAY REAGENTS Sclavo, Inc. DGP Class II 1986-12-03
K864207 DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO Gamma Biologicals, Inc. KTN Class II 1986-12-03
K863794 3M IGG4 FAST TEST PACKAGE 3M Company DHB Class II 1986-12-03
K863394 RAPID SPECIFIC IGE PROCEDURE Allertec, Inc. DHB Class II 1986-12-03
K862087 SANTEST 1AP Scientific Sales Intl., Inc. LKL Class I 1986-12-03
K863973 ELM ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-12-01
K864342 MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX Eiken Chemical Co., Inc. CFN Class II 1986-12-01
K864130 ABBOTT B2-MICROGLOBULIN RIA Abbott Laboratories JZG Class II 1986-11-12
K863858 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- Hybritech, Inc. DGC Class II 1986-11-03
K863822 ENZYMUN-TEST(R) IGE Boehringer Mannheim Corp. DGC Class II 1986-10-29
K863844 IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-10-29
K863434 THE FIAX 5000 FLUOROMETER Whittaker Bioproducts, Inc. JZT Class I 1986-10-29
K863717 ANTI-DNA MICROASSAY Diamedix Corp. DHN Class II 1986-10-24
K862969 ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT Biohytech International, Inc. LJM Class II 1986-10-24
K863628 C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS Technicon Instruments Corp. DCK Class II 1986-10-15
K863730 MYOLEX Orion Corp. DDR Class II 1986-10-15
K863345 TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY Hybritech, Inc. DBF Class II 1986-10-08
K863238 READS RF TEST KIT FOR IGM RHEUMATOID FACTOR Biostar Medical Products, Inc. DHR Class II 1986-10-08
K863036 PHADEBAS RAST/PHADEZYM RAST ALLERTUBE Pharmacia, Inc. DHB Class II 1986-10-03
K863123 IMMUNO BIOTECH MUGWART ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-10-01
K863487 QUANTIMUNE(R) FERRITIN IRMA Bio-Rad DBF Class II 1986-10-01
K863329 ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. DCK Class II 1986-09-26
K863328 ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST E.I. Dupont DE Nemours & Co., Inc. DCK Class II 1986-09-26
K862671 MICROALBUMINURIA ASSAY Orion Corp. DCF Class II 1986-09-18
K863355 PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA Pharmacia, Inc. DHB Class II 1986-09-17
K863352 PRECIMAT (R) IGA, G, M Boehringer Mannheim Corp. CZP Class II 1986-09-17
K862901 VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. DHB Class II 1986-09-16
K863098 MEADOW FESCUE ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-09-15
K862762 TINA-QUANT(R) IGM Boehringer Mannheim Corp. DFT Class II 1986-09-08
K863006 125-I TSH RECEPTOR ANTIBODY KIT Cronus JZO Class II 1986-09-08
K862763 TINA-QUANT(R) IGA Boehringer Mannheim Corp. CZP Class II 1986-09-04
K862649 CYTOTECH CIC ENZYME IMMUNOASSAY Cytotech, Inc. DAK Class II 1986-09-04
K862764 TINA-QUANT(R) IGG Boehringer Mannheim Corp. DEW Class II 1986-09-03
K862960 PHASE II FERRITIN RADIOIMMUNOASSAY KIT Medical & Scientific Designs, Inc. DBF Class II 1986-08-27
K854944 TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT Abbott Laboratories DAH Class II 1986-08-27
K855046 TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT Abbott Laboratories CZP Class II 1986-08-27
K861059 DAKO ITA SYSTEM Dako Corp. DEW Class II 1986-08-25
K862700 SERATEST ENA [SS-B] KIT Hemagen Diagnostics, Inc. LLL Class II 1986-08-19
K862184 DAKO ITA, IMMUNOGLOBULIN M (IGM) Dako Corp. DAH Class II 1986-08-19
K862266 MAPLE ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-08-19
K862183 DAKO ITA, IMMUNOGLOBULIN A (IGA) Dako Corp. CZP Class II 1986-08-19
K862265 COTTONWOOD ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-08-15
K862176 RUSSIAN THISTLE ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-08-15
K862939 ORCHARD GRASS ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-08-15
K862821 CAPPEL DIAGNOSTICS ANA KIT Cappel Diagnostics, Inc. DHN Class II 1986-08-15
K862674 PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM Hybritech, Inc. JZT Class I 1986-08-15
K862938 JUNE GRASS ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-08-15
K862313 KALLESTAD SM/RNP TEST REAGENT Kallestad Laboratories, Inc. LKJ Class II 1986-08-06
K862174 TIMOTHY ALLERGEN DISC Immuno Nuclear Corp. DGC Class II 1986-08-06
K860679 IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN Orion Corp. DCN Class II 1986-08-04
K862710 KALLESTAD SSA/SSB ENA TEST REAGENTS Kallestad Laboratories, Inc. LLL Class II 1986-07-29
K861773 ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM Zygotek Systems, Inc. DGB Class I 1986-07-07
K862173 PERENNIAL RYE ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-07-03
K862008 MONO-LATEX (TM) SLIDE TEST Armkel, LLC KTN Class II 1986-07-03
K862368 AMPLIFIED ELISA IGE KIT Allertec, Inc. DGC Class II 1986-07-03
K862264 ENGLISH PLAINTAIN ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-07-03
K861499 BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT Biostar Medical Products, Inc. DAK Class II 1986-06-20
K862175 WHITE OAK ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-06-20
K862014 IMMPULSE FERRITIN ASSAY REAGENT Sclavo, Inc. DBF Class II 1986-06-19
K860550 DU PONT C-REACTIVE PROTEIN (CRP) ASSAY E.I. Dupont DE Nemours & Co., Inc. DCK Class II 1986-06-10
K860549 DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. DCK Class II 1986-06-10
K861978 AUTOFLUOR V Technia Diagnostics , Ltd. KTL Class II 1986-06-10
K861362 IMMUNOMEDICS SERUM ELISA TEST SYSTEM Immunomedics, Inc. CZW Class II 1986-06-06
K854756 SHORT RAGWEED ALLERGEN DISC Immuno Nuclear Corp. DHB Class II 1986-05-15
K860428 SM-RNP AUTOANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1986-05-15
K861452 MONOSTAR SYSTEM: IM LATEX TEST U.S. Health Resources Corp. KTN Class II 1986-05-13
K861336 IAP PLATE TEST Scientific Sales Intl., Inc. LKL Class I 1986-04-25
K861167 IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST Atlantic Antibodies CZP Class II 1986-04-25
K861184 PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1986-04-25
K861171 QUIDEL ALLERGY SCREEN Quidel Corp. DGC Class II 1986-04-25
K855221 SERATEST RF (HEMAGGLUTINATION) KIT Hemagen Diagnostics, Inc. DHR Class II 1986-04-22
K854865 PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5 Pharmacia, Inc. DHB Class II 1986-04-22
K855053 THABEST-IGE Visual Diagnostics, Inc. DHB Class II 1986-04-22
K860027 FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY Alerchek, Inc. DHB Class II 1986-04-22
K861016 GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS Gamma Biologicals, Inc. KTN Class II 1986-04-18
K860894 BEHRING NEPHELOMETER SYSTEM Behring Diagnostics, Inc. CFN Class II 1986-04-15
K860032 TOTAL IGE-IRMA RIA KIT Diagnostic Products Corp. DGC Class II 1986-04-11
K860033 EIA MONOCLONAL TOTAL IGE KIT Diagnostic Products Corp. DGC Class II 1986-04-07
K860138 NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM Sigma Diagnostics, Inc. DDB Class II 1986-03-28
K860644 SS-A/SS-B AUTOANTIBODY TEST SYSTEM Immuno Concepts, Inc. LLL Class II 1986-03-28
K860851 ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM Nichols Institute Diagnostics DGO Class II 1986-03-28
K860137 ENZYMUN-TEST FERRITIN Boehringer Mannheim Corp. DBF Class II 1986-03-28
K855010 QUANTIMETRIC PLUS IGM REAGENT KIT Kallestad Laboratories, Inc. DFT Class II 1986-02-28
K860183 AFT-HEP SYSTEM Behring Diagnostics, Inc. DHN Class II 1986-02-26
K855013 QUANTIMETRIC PLUS SUPPORT PACK Kallestad Laboratories, Inc. DEH Class II 1986-02-26
K855009 QUANTIMETRIC PLUS IGA REAGENT KIT Kallestad Laboratories, Inc. CZP Class II 1986-02-26
K855012 QUANTIMETRIC PLUS C4 REAGENT KIT Kallestad Laboratories, Inc. DBI Class II 1986-02-26
K855057 LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) Behring Diagnostics, Inc. DCN Class II 1986-02-26
K854819 CPR SLIDE EIKEN Syn-Kit, Inc. DCN Class II 1986-02-26
K855011 QUANTIMETRIC PLUS C3 REAGENT KIT Kallestad Laboratories, Inc. CZN Class II 1986-02-26
K854572 COATEST PLASMINOGEN Kabivitrum, Inc. DDX Class I 1986-02-26
K855007 QUANTIMETRIC PLUS LAMBDA REAGENT KIT Kallestad Laboratories, Inc. DEH Class II 1986-02-26
K855008 QUANTIMETRIC PLUS KAPPA REAGENT KIT Kallestad Laboratories, Inc. DFH Class II 1986-02-26
K854416 TDX TRANSFERRIN DIAGNOSTIC KIT Abbott Laboratories DDG Class II 1986-02-21
K854939 PHADEBAS RAST/PHADEZYM RAST ALLERTUBES Pharmacia, Inc. DHB Class II 1986-02-13

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