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Immunology

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

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RecordFirmDate
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 (K984473)Bio-Rad1998-12-22
REAADS IGA ANTI-B2GP 1 TEST KIT (K982434)Corgenix, Inc.1998-12-22
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM (K984173)Zeus Scientific, Inc.1998-12-22
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 (K984479)Bio-Rad1998-12-22
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (K984476)Bio-Rad1998-12-22
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 (K984470)Bio-Rad1998-12-22
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 (K984478)Bio-Rad1998-12-22
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 (K984464)Bio-Rad1998-12-22
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 (K984475)Bio-Rad1998-12-22
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 (K984462)Bio-Rad1998-12-22
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (K983924)Immuno Concepts, Inc.1998-12-18
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 (K984400)Bio-Rad1998-12-18
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 (K984398)Bio-Rad1998-12-18
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 (K984397)Bio-Rad1998-12-18
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 (K984399)Bio-Rad1998-12-18
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031)Ortho-Clinical Diagnostics, Inc.1998-12-18
TRANSFERRIN SPQ III ANTIBODY REAGENT SET (K983880)DiaSorin, Inc.1998-12-18
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (K984396)Bio-Rad1998-12-18
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE (K984315)Zeus Scientific, Inc.1998-12-17
ALASTAT MICROPLATE MIXED ALLERGEN PANELS (K983954)Diagnostic Products Corp.1998-12-17
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F (K984347)Zeus Scientific, Inc.1998-12-17
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM (K984175)Zeus Scientific, Inc.1998-12-17
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR (K983340)Beckman Coulter, Inc.1998-12-14
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK (K984065)Dade Behring, Inc.1998-12-14
CLEARVIEW IM (K981946)Unipath , Ltd.1998-12-10
MYOGLOBIN FLEX REAGENT CARTRIDGE (K984191)Dade Behring, Inc.1998-12-10
BTA STAT TEST PRESCRIPTION HOME USE (K974845)Bard Diagnostic Sciences,Inc.1998-12-08
REAADS IGG ANTI-B2GPI TEST KIT (K982391)Corgenix, Inc.1998-12-07
REAADS IGM ANTI-B2GP1 TEST KIT (K982433)Corgenix, Inc.1998-12-07
ABBOTT ARCHITECT FERRITIN (K983759)Abbott Laboratories1998-12-07
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263)Diagnostic Products Corp.1998-12-07
ANTI-TG IGG ELISA TEST SYSTEM (K983553)Columbia Bioscience, Inc.1998-12-07
HUMAN IGA SUBCLASS BNII COMBI KIT (K981912)The Binding Site, Ltd.1998-12-04
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM (K982898)Immco Diagnostics, Inc.1998-11-30
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984034)Zeus Scientific, Inc.1998-11-30
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 (K983970)Diagnostic Products Corp.1998-11-25
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT (K983895)Beckman Coulter, Inc.1998-11-25
IS-ANTI-PR3 IGG ELISA TEST SYSTEM (K983740)Columbia Bioscience, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC (K983426)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S (K983376)Zeus Scientific, Inc.1998-11-18
IS-ANTI-MPO IGG ELISA TEST SYSTEM (K983390)Columbia Bioscience, Inc.1998-11-18
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET (K983425)Zeus Scientific, Inc.1998-11-18
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL (K983418)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET (K983422)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983465)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983423)Zeus Scientific, Inc.1998-11-18
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO (K983420)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. (K983378)Zeus Scientific, Inc.1998-11-18
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K983464)Zeus Scientific, Inc.1998-11-18
ABBOTT AXSYM MYOGLOBIN (K983848)Abbott Laboratories1998-11-16
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (K983185)Boehringer Mannheim Corp.1998-11-12
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (K981871)Diagnostic Systems Laboratories, Inc.1998-11-09
QUANTA LITE RF IGA ELISA (K983084)Inova Diagnostics, Inc.1998-11-04
IGA (K983359)Abbott Laboratories1998-11-04
C3 (K983441)Abbott Laboratories1998-11-04
TRF (K983167)Abbott Laboratories1998-11-04
SPIFE URINE IFE (K982639)Helena Laboratories1998-11-04
C4 (K983356)Abbott Laboratories1998-11-04
IGM (K983132)Abbott Laboratories1998-11-04
QUANTA LITE RF IGG ELISA (K983083)Inova Diagnostics, Inc.1998-11-04
IGG (K983221)Abbott Laboratories1998-11-04
ELECSYS PSA, MODEL 2010 (K982949)Boehringer Mannheim Corp.1998-10-27
ELECSYS PSA, MODEL # ELECSYS 1010 (K982948)Boehringer Mannheim Corp.1998-10-27
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY (K982714)Bayer Corp.1998-10-22
UNICAP GLIADIN IGA ASSAY (K982533)Pharmacia & Upjohn Co.1998-10-22
MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS (K981209)The Binding Site, Ltd.1998-10-22
UNICAP GLIADIN IGG ASSAY (K982701)Pharmacia & Upjohn Co.1998-10-22
TFR (K981208)Ramco Laboratories, Inc.1998-10-21
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 (K982866)Nichols Institute Diagnostics1998-10-16
TINAQUANT B 2-MICROGLOBULIN ASSAY (K980724)Boehringer Mannheim Corp.1998-10-16
IMMULITE 2000 OM-MA MODEL L2KOP2 (K983391)Diagnostic Products Corp.1998-10-15
SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (K982879)Shield Diagnostics, Ltd.1998-10-15
CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (K982680)Chiron Diagnostics Corp.1998-10-15
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS (K981634)Biocircuits Corp.1998-10-13
AIA-PACK TPOAB ASSAY (K981521)Tosoh Medics, Inc.1998-10-08
AIA-PACK TGAB ASSAY (K981522)Tosoh Medics, Inc.1998-10-08
QUANTA LITE CHROMATIN ELISA (K982603)Inova Diagnostics, Inc.1998-10-07
HYDRAGEL 6 CSF KIT (K981048)Morax1998-10-07
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (K982679)Spectral Diagnostics, Inc.1998-10-07
IMX HOMOCYSTEINE (K980812)Axis Biochemicals, Asa1998-10-01
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES (K973203)Sangstat Medical Corp.1998-09-30
COBAS INTEGRA REAGENT CASSETTES (K982382)Roche Diagnostic Systems, Inc.1998-09-28
ELECSYS MYOGLOBIN STAT ASSAY (K983176)Boehringer Mannheim Corp.1998-09-24
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 (K981985)Beckman Coulter, Inc.1998-09-24
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 (K981297)Diagnostic Products Corp.1998-09-18
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (K982121)Trace Scientific , Ltd.1998-09-17
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 (K982343)Pharmacia & Upjohn Co.1998-09-15
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (K982023)Inova Diagnostics, Inc.1998-09-04
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT (K981929)The Binding Site, Ltd.1998-09-03
BINDAZYME ANTIGLIADIN IGG (K981644)The Binding Site, Ltd.1998-09-03
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA (K982366)Inova Diagnostics, Inc.1998-08-27
ROCHE CRP T CONTROL N (K982087)Roche Diagnostic Systems, Inc.1998-08-18
EL-ANA PROFILES: EL-ENA/4 (K982150)Theratest Laboratories, Inc.1998-08-13
EL-ANA PROFILES: EL-ENA/5 (K982622)Theratest Laboratories, Inc.1998-08-13
ACS:CENTAUR PSA2 IMMUNOASSAY (K981839)Chiron Diagnostics Corp.1998-08-12
ACS:CENTAUR CEA (K981478)Chiron Diagnostics Corp.1998-08-12
ACTIVE PSA ELISA (DSL-10-9700) (K973243)Diagnostic Systems Laboratories, Inc.1998-08-03
ACTIVE PSA IRMA (DSL-9700) (K973244)Diagnostic Systems Laboratories, Inc.1998-08-03
QUANTA LITE TPO ELISA (K981857)Inova Diagnostics, Inc.1998-07-29
QUIDEL CH50 EQ EIA (K974111)Quidel Corp.1998-07-29
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