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Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
38
Latest Decision
1986-02-06

Clearances · page 29 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854222 DIESSE RF TEST KIT Marvic Interpharma, Inc. DHR Class II 1986-02-06
K854384 ASSERACHROM FPA KIT American Bioproducts Co. DAN Class II 1986-02-04
K854542 TDX C-REACTIVE PROTEIN Abbott Laboratories DCK Class II 1986-01-24
K854875 APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 Photec Diagnostics, Inc. DER Class II 1986-01-24
K854811 ICS PAB PREALBUMIN REAGENT TEST KIT Beckman Instruments, Inc. DDS Class I 1986-01-24
K854820 RA 80 EIKEN Syn-Kit, Inc. DHR Class II 1986-01-17
K853697 BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT Biostar Medical Products, Inc. DAK Class II 1985-12-16
K854314 FANA 60 American Bio-Reagents, Inc. DHN Class II 1985-12-16
K854483 KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT Kallestad Laboratories, Inc. KTO Class I 1985-12-11
K850683 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 Kent Laboratories, Inc. DEB Class II 1985-11-27
K854190 CANTROL SPINAL FLUID CONTROL Canyon Diagnostics, Inc. DFI Class I 1985-11-25
K854221 DIESSE CRP TEST KIT Marvic Interpharma, Inc. DCK Class II 1985-11-25
K850682 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL Kent Laboratories, Inc. DDB Class II 1985-11-25
K853969 PHADEBAS RAST TEST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1985-11-18
K853607 ALLERG-E IGE ENZYME IMMUNOASSAY KIT Dexall Biomedical Labs, Inc. DGO Class II 1985-11-07
K850686 ANTISERUM TO HUMAN PREALBUMIN Kent Laboratories, Inc. JZJ Class I 1985-11-01
K852737 LACTOPLATE Mackeen Consultants, Ltd. DEG Class I 1985-10-25
K852999 QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT Kallestad Laboratories, Inc. DEH Class II 1985-10-21
K850895 VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY Ventrex Laboratories, Inc. DHB Class II 1985-10-16
K853144 CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 Preco, Inc. KTN Class II 1985-10-16
K852794 ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. DHB Class II 1985-09-19
K853456 PHADEBAS RAST/PHADEZYM RAST ALLERTUBES Pharmacia, Inc. DHB Class II 1985-09-19
K853468 GILFORD C4 COMPLEMENT REAGENT Gilford DBI Class II 1985-09-16
K853466 GILFORD C3 COMPLEMENT REAGENT Gilford CZW Class II 1985-09-16
K853469 GILFORD IMMUNOGLOBULIN M REAGENT Gilford DFT Class II 1985-09-16
K853467 GILFORD IMMUNOGLOBULIN A REAGENT Gilford CZP Class II 1985-09-16
K853465 GILFORD IMMUNOGLOBULIN G REAGENT Gilford DEW Class II 1985-09-16
K853105 IMMUNO-IM Immunostics Co., Inc. KTN Class II 1985-09-03
K852878 THE DPC MONOCLONAL EIA TOTAL IGE KIT Diagnostic Products Corp. DGC Class II 1985-08-28
K853048 APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 Photec Diagnostics, Inc. DER Class II 1985-08-28
K853025 IMAGE-IGE Clinical Reference Laboratory, Inc. DGC Class II 1985-08-22
K853388 MONOSTICON UNI-DOT Organon, Inc. KTN Class II 1985-08-22
K853261 LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) Behring Diagnostics, Inc. CZS Class I 1985-08-22
K853054 RF CARD TEST Preco, Inc. DHR Class II 1985-08-01
K852840 ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST Modern Diagnostics, Inc. LJM Class II 1985-08-01
K851891 TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS Richard Scott Elliott LOJ Class II 1985-07-19
K851541 DART IMMUNOGLOBULINS REAGENT SYSTEM Coulter Electronics, Inc. DEW Class II 1985-07-15
K852589 TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT Abbott Laboratories DEW Class II 1985-07-15
K852189 PHADEBAS RAST TEST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1985-07-15
K852230 ANA/LITE-RL TEST SYSTEM Immuno-Products Industries LJM Class II 1985-07-10
K852268 QUANTICLONE IGE RADIOIMMUNASSAY Kallestad Laboratories, Inc. DGC Class II 1985-07-10
K852247 LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) Behring Diagnostics, Inc. DDB Class II 1985-07-10
K852231 ANA/LITE-HEP-2 TEST SYSTEM Immuno-Products Industries LJM Class II 1985-07-10
K852263 PHADEBAS RAST/PHADEZYM RAST ALLERTUBES Pharmacia, Inc. DHB Class II 1985-06-27
K852033 SS-A(RO) & SS-B(LA) ANTIBODY ASSAY Meloy Laboratories, Inc. DHN Class II 1985-06-21
K851912 LASER PREALBUMIN TEST Behring Diagnostics, Inc. JZJ Class I 1985-06-21
K851285 RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI Cooper Biomedical, Inc. DCF Class II 1985-06-17
K852240 SMS, SCREEN MACHINE SYSTEM Pandex Laboratories, Inc. JZT Class I 1985-06-11
K851284 RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM Cooper Biomedical, Inc. CZP Class II 1985-06-11
K851537 LASER RF CONTROL SERUM-QUALITY CONTROL SERUM Behring Diagnostics, Inc. DHR Class II 1985-06-05
K851286 RADIAL IMMUNODIFFUSION PLATES C3 & C4 Cooper Biomedical, Inc. CZW Class II 1985-06-05
K851649 APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 Photec Diagnostics, Inc. DER Class II 1985-06-05
K851842 SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN Atlantic Antibodies DCK Class II 1985-06-05
K851512 ALLERGENETICS IGE FAST TEST Allergenetics DHB Class II 1985-05-28
K851282 RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI Cooper Biomedical, Inc. DEB Class II 1985-05-24
K851287 RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN Cooper Biomedical, Inc. DDG Class II 1985-05-24
K851283 RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN Cooper Biomedical, Inc. DDB Class II 1985-05-23
K851273 PHADEBAS RAST PHADEZYM RAST ALLERTUBES Pharmacia, Inc. DHB Class II 1985-05-21
K851369 ANTINUCLEAR ANTIBODY TEST KIT Modern Diagnostics, Inc. DHN Class II 1985-05-15
K850410 GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY Warner-Lambert Co. DDX Class I 1985-05-08
K851202 GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL Gilford DAK Class II 1985-04-29
K851099 IGM RHEUMATOID FACTOR TEST KIT Breit Laboratories, Inc. DHR Class II 1985-04-25
K851156 PHARMACIA IGE RIA MODIFIED Pharmacia, Inc. DGC Class II 1985-04-25
K850160 FISHER DIAGNOSTICS LATEST-CRP TEST KIT Fisher Diagnostics DCK Class II 1985-04-19
K844629 MAST LUMINESCENT ALLERGY SYSTEM Mast Immunosystems DHB Class II 1985-04-12
K843694 MAST ALLERGY SYSTEM Mast Immunosystems DHB Class II 1985-04-12
K850296 LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS Behring Diagnostics, Inc. DHR Class II 1985-04-12
K850786 TOTAL HIGE ENZYME IMMUNOASSAY Nms Pharmaceuticals, Inc. DGC Class II 1985-04-12
K845032 PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1985-03-21
K850586 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M Applications Lab DAO Class II 1985-03-14
K850587 SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN Applications Lab DEM Class II 1985-03-14
K842991 AUTOFLUOR V SYSTEM Tech America Diagnostics DHN Class II 1985-03-14
K850603 SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN Applications Lab DEB Class II 1985-03-05
K850584 SPQ TEST SYSTEM FOR HAPTOGLOBIN Applications Lab DAD Class II 1985-03-05
K850589 SPQ TEST SYSTEM FOR TRANSFERRIN Applications Lab DDG Class II 1985-03-05
K850588 SPQ TEST SYSTEM FOR COMPLEMENT C3 Applications Lab CZW Class II 1985-03-05
K850582 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A Applications Lab CZP Class II 1985-03-01
K850585 SPQ TEST SYSTEM FOR COMPLEMENT C4 Applications Lab DBI Class II 1985-03-01
K850590 SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN Applications Lab DCK Class II 1985-03-01
K850583 SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G Applications Lab DEW Class II 1985-03-01
K850373 ABBOTT RF EIA DIAGNOSTIC KIT Abbott Laboratories DHR Class II 1985-03-01
K843423 PHYSIO GAS ANALYZER Research Medical, Inc. LLL Class II 1985-02-26
K844469 PHARMACIA B2-MICRO EIA Pharmacia, Inc. JZG Class II 1985-02-14
K844743 SERATEST ENA(RNP/SM) DETERMINATION Seragen Diagnostics, Inc. LLL Class II 1985-02-04
K844294 CORDIA IC Cordis Corp. DAK Class II 1985-02-04
K844678 MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL Meloy Laboratories, Inc. DHN Class II 1985-01-04
K843978 ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY Behring Diagnostics, Inc. LLL Class II 1984-12-18
K843967 ENZYGNOST BETA-2 MICROGLOBULIN TEST Behring Diagnostics, Inc. JZG Class II 1984-12-03
K842049 FLUOROSKAN Flow Laboratories, Inc. JZT Class I 1984-12-03
K843122 RESOLVE-CSF Isolab, Inc. DFI Class I 1984-11-30
K844158 STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY American Dade DBF Class II 1984-11-19
K844289 SERIES I/S INFECTIONS American Dade KTN Class II 1984-11-19
K843369 AGGLUTINATION TEST FOR TOTAL IGE Scientific Research DGC Class II 1984-11-14
K841984 AUTOFLOUR III SYSTEM Tech America Diagnostics DHN Class II 1984-11-01
K843225 COLORZYME NDNA TEST SYSTEM Immuno Concepts, Inc. DHN Class II 1984-11-01
K843904 DNA STAT TEST KIT Whittaker Bioproducts, Inc. LJM Class II 1984-11-01
K842563 SERATEST DNA DETERMINATION Seragen Diagnostics, Inc. LKJ Class II 1984-10-25
K843896 RHEUMADX LATEX AGGLUTINATION RHEUMATOID Diagnostic Products Corp. DHR Class II 1984-10-25
K843745 ADP ANA APPLEZYME Apple Diagnostic Products LJM Class II 1984-10-25
K843343 MEDICA IIF-ANTI-THYROID ANTIBODY TEST Medical Diagnostics, Ca. JZO Class II 1984-10-22

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