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Immunology

3,537 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
CANTROL SPINAL FLUID CONTROL (K854190)Canyon Diagnostics, Inc.1985-11-25
DIESSE CRP TEST KIT (K854221)Marvic Interpharma, Inc.1985-11-25
PHADEBAS RAST TEST ALLERGEN DISCS (K853969)Pharmacia, Inc.1985-11-18
ALLERG-E IGE ENZYME IMMUNOASSAY KIT (K853607)Dexall Biomedical Labs, Inc.1985-11-07
ANTISERUM TO HUMAN PREALBUMIN (K850686)Kent Laboratories, Inc.1985-11-01
LACTOPLATE (K852737)Mackeen Consultants, Ltd.1985-10-25
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT (K852999)Kallestad Laboratories, Inc.1985-10-21
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY (K850895)Ventrex Laboratories, Inc.1985-10-16
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 (K853144)Preco, Inc.1985-10-16
ALLERCOAT ALLERGEN DISCS (K852794)Kallestad Laboratories, Inc.1985-09-19
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES (K853456)Pharmacia, Inc.1985-09-19
GILFORD IMMUNOGLOBULIN G REAGENT (K853465)Gilford1985-09-16
GILFORD IMMUNOGLOBULIN A REAGENT (K853467)Gilford1985-09-16
GILFORD IMMUNOGLOBULIN M REAGENT (K853469)Gilford1985-09-16
GILFORD C3 COMPLEMENT REAGENT (K853466)Gilford1985-09-16
GILFORD C4 COMPLEMENT REAGENT (K853468)Gilford1985-09-16
IMMUNO-IM (K853105)Immunostics Co., Inc.1985-09-03
THE DPC MONOCLONAL EIA TOTAL IGE KIT (K852878)Diagnostic Products Corp.1985-08-28
APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 (K853048)Photec Diagnostics, Inc.1985-08-28
MONOSTICON UNI-DOT (K853388)Organon, Inc.1985-08-22
LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) (K853261)Behring Diagnostics, Inc.1985-08-22
IMAGE-IGE (K853025)Clinical Reference Laboratory, Inc.1985-08-22
ENZYME ANTINUCLEAR ANTIBODY SCREENING TEST (K852840)Modern Diagnostics, Inc.1985-08-01
RF CARD TEST (K853054)Preco, Inc.1985-08-01
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS (K851891)Richard Scott Elliott1985-07-19
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT (K852589)Abbott Laboratories1985-07-15
DART IMMUNOGLOBULINS REAGENT SYSTEM (K851541)Coulter Electronics, Inc.1985-07-15
PHADEBAS RAST TEST ALLERGEN DISCS (K852189)Pharmacia, Inc.1985-07-15
ANA/LITE-HEP-2 TEST SYSTEM (K852231)Immuno-Products Industries1985-07-10
QUANTICLONE IGE RADIOIMMUNASSAY (K852268)Kallestad Laboratories, Inc.1985-07-10
ANA/LITE-RL TEST SYSTEM (K852230)Immuno-Products Industries1985-07-10
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) (K852247)Behring Diagnostics, Inc.1985-07-10
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES (K852263)Pharmacia, Inc.1985-06-27
LASER PREALBUMIN TEST (K851912)Behring Diagnostics, Inc.1985-06-21
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY (K852033)Meloy Laboratories, Inc.1985-06-21
RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI (K851285)Cooper Biomedical, Inc.1985-06-17
SMS, SCREEN MACHINE SYSTEM (K852240)Pandex Laboratories, Inc.1985-06-11
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM (K851284)Cooper Biomedical, Inc.1985-06-11
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM (K851537)Behring Diagnostics, Inc.1985-06-05
RADIAL IMMUNODIFFUSION PLATES C3 & C4 (K851286)Cooper Biomedical, Inc.1985-06-05
APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 (K851649)Photec Diagnostics, Inc.1985-06-05
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (K851842)Atlantic Antibodies1985-06-05
ALLERGENETICS IGE FAST TEST (K851512)Allergenetics1985-05-28
RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI (K851282)Cooper Biomedical, Inc.1985-05-24
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN (K851287)Cooper Biomedical, Inc.1985-05-24
RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN (K851283)Cooper Biomedical, Inc.1985-05-23
PHADEBAS RAST PHADEZYM RAST ALLERTUBES (K851273)Pharmacia, Inc.1985-05-21
ANTINUCLEAR ANTIBODY TEST KIT (K851369)Modern Diagnostics, Inc.1985-05-15
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (K850410)Warner-Lambert Co.1985-05-08
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL (K851202)Gilford1985-04-29
PHARMACIA IGE RIA MODIFIED (K851156)Pharmacia, Inc.1985-04-25
IGM RHEUMATOID FACTOR TEST KIT (K851099)Breit Laboratories, Inc.1985-04-25
FISHER DIAGNOSTICS LATEST-CRP TEST KIT (K850160)Fisher Diagnostics1985-04-19
TOTAL HIGE ENZYME IMMUNOASSAY (K850786)Nms Pharmaceuticals, Inc.1985-04-12
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS (K850296)Behring Diagnostics, Inc.1985-04-12
MAST LUMINESCENT ALLERGY SYSTEM (K844629)Mast Immunosystems1985-04-12
MAST ALLERGY SYSTEM (K843694)Mast Immunosystems1985-04-12
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS (K845032)Pharmacia, Inc.1985-03-21
AUTOFLUOR V SYSTEM (K842991)Tech America Diagnostics1985-03-14
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (K850587)Applications Lab1985-03-14
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (K850586)Applications Lab1985-03-14
SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN (K850603)Applications Lab1985-03-05
SPQ TEST SYSTEM FOR TRANSFERRIN (K850589)Applications Lab1985-03-05
SPQ TEST SYSTEM FOR HAPTOGLOBIN (K850584)Applications Lab1985-03-05
SPQ TEST SYSTEM FOR COMPLEMENT C3 (K850588)Applications Lab1985-03-05
ABBOTT RF EIA DIAGNOSTIC KIT (K850373)Abbott Laboratories1985-03-01
SPQ TEST SYSTEM FOR COMPLEMENT C4 (K850585)Applications Lab1985-03-01
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (K850583)Applications Lab1985-03-01
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A (K850582)Applications Lab1985-03-01
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN (K850590)Applications Lab1985-03-01
PHYSIO GAS ANALYZER (K843423)Research Medical, Inc.1985-02-26
PHARMACIA B2-MICRO EIA (K844469)Pharmacia, Inc.1985-02-14
SERATEST ENA(RNP/SM) DETERMINATION (K844743)Seragen Diagnostics, Inc.1985-02-04
CORDIA IC (K844294)Cordis Corp.1985-02-04
MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL (K844678)Meloy Laboratories, Inc.1985-01-04
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY (K843978)Behring Diagnostics, Inc.1984-12-18
FLUOROSKAN (K842049)Flow Laboratories, Inc.1984-12-03
ENZYGNOST BETA-2 MICROGLOBULIN TEST (K843967)Behring Diagnostics, Inc.1984-12-03
RESOLVE-CSF (K843122)Isolab, Inc.1984-11-30
SERIES I/S INFECTIONS (K844289)American Dade1984-11-19
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY (K844158)American Dade1984-11-19
AGGLUTINATION TEST FOR TOTAL IGE (K843369)Scientific Research1984-11-14
COLORZYME NDNA TEST SYSTEM (K843225)Immuno Concepts, Inc.1984-11-01
DNA STAT TEST KIT (K843904)Whittaker Bioproducts, Inc.1984-11-01
AUTOFLOUR III SYSTEM (K841984)Tech America Diagnostics1984-11-01
SERATEST DNA DETERMINATION (K842563)Seragen Diagnostics, Inc.1984-10-25
ADP ANA APPLEZYME (K843745)Apple Diagnostic Products1984-10-25
RHEUMADX LATEX AGGLUTINATION RHEUMATOID (K843896)Diagnostic Products Corp.1984-10-25
ELISA FOR TOTAL IGE (K843710)Scientific Research1984-10-22
TSH RECEPTOR ANTIBODY KIT 125I TSH (K841580)Clinetics Corp.1984-10-22
MEDICA IIF-ANTI-THYROID ANTIBODY TEST (K843343)Medical Diagnostics, Ca.1984-10-22
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON (K843347)E.I. Dupont DE Nemours & Co., Inc.1984-10-05
FIAX HAPTOGLOBIN TEST KIT (K843570)Intl. Diagnostic Technology1984-10-05
CORNING IMMUNOFIXATION SYS (K843614)Corning Medical & Scientific1984-10-05
NEW ALLERG. COATED MICROFILTER WELL STRI (K843302)Diagnostic Reagent Tech.1984-10-04
ENCORE IGE REAGENT (K843408)Hybritech, Inc.1984-10-01
AMIZYME-ANA TEST KIT (K842532)Amico Lab, Inc.1984-09-20
AMIZYME-ANDNA TEST KIT (K842533)Amico Lab, Inc.1984-09-20
AUTOFLUOR IV SYSTEM (K843181)Tech America Diagnostics1984-09-17
FIAX 100 FLUOROMETER (K843356)Intl. Diagnostic Technology1984-09-17
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