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Immunology

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

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RecordFirmDate
TRUCATH.IP (K023368)Aortech Critical Care , Ltd.2002-10-28
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA (K023285)Axis-Shield Diagnostics, Ltd.2002-10-09
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 (K022992)Corgenix, Inc.2002-09-25
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 (K022990)Corgenix, Inc.2002-09-25
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA (K021648)Inova Diagnostics, Inc.2002-09-20
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (K021057)Brahms Diagnostica, LLC2002-09-17
CONVOY ADVANCED DELIVERY SHEATH (K022067)Boston Scientific2002-09-11
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET (K020972)Wako Chemicals USA, Inc.2002-09-09
APL IGA ELISA KIT (K021398)Louisville Apl Diagnostics, Inc.2002-08-27
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
K-ASSAY HS-CRP CONTROLS (K022486)Kamiya Biomedical Co.2002-08-14
RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (K022017)Rhigene, Inc.2002-08-14
ELECSYS ANTI-TG TEST SYSTEM (K020672)Roche Diagnostics Corp.2002-08-05
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA (K021482)Inova Diagnostics, Inc.2002-07-30
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT (K021231)Matritech, Inc.2002-07-30
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (K013263)Fred Hutchinson Cancer Research Center2002-07-29
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (K021194)Hemagen Diagnostics, Inc.2002-07-29
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET (K021757)Good Biotech Corp.2002-07-29
K-ASSAY LP(A) ASSAY (K021660)Kamiya Biomedical Co.2002-07-25
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K020828)Bayer Corp.2002-07-24
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 (K021516)Axis-Shield Diagnostics, Ltd.2002-07-23
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR (K021572)Beckman Coulter, Inc.2002-07-19
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER (K022083)The Binding Site, Ltd.2002-07-16
QAB2A IGM ELISA KIT HRP (K021610)Cheshire Diagnostics , Ltd.2002-07-12
QAB2A IGG ELISA KIT HRP (K021611)Cheshire Diagnostics , Ltd.2002-07-12
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 (K021882)Good Biotech Corp.2002-07-11
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (K021394)Diamedix Corp.2002-07-09
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (K022018)Rhigene, Inc.2002-07-05
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 (K021229)Beckman Coulter, Inc.2002-06-28
RDI HS CRP KIT (K021609)Reference Diagnostics, Inc.2002-06-27
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER (K021081)The Binding Site, Ltd.2002-06-17
CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 (K020603)Good Biotech Corp.2002-06-13
HYPERION VISIQUANT ANA TEST KIT (K013213)Hyperion, Inc.2002-06-04
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (K021257)Diagnostic Products Corp.2002-06-03
IMMULITE 2000 SPECIFIC ALLERGENS (K021206)Diagnostic Products Corp.2002-05-30
IMMULITE 2000 MIXED ALLERGEN PANELS (K021208)Diagnostic Products Corp.2002-05-30
QACA IGG/IGM ELISA KIT HRP (K021192)Cheshire Diagnostics , Ltd.2002-05-16
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT (K020823)Sanquin Blood Supply Foundation2002-05-14
NYCOCARD CRP (K013787)Primus Corp.2002-05-14
FUJIREBIO DIAGNOSTICS CA 19-9 RIA (K020566)Fujirebio Diagnostics,Inc.2002-05-09
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 (K020752)Pharmacia Deutschland GmbH2002-05-02
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 (K020757)Pharmacia Deutschland GmbH2002-05-02
DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 (K020687)Axis-Shield Diagnostics, Ltd.2002-05-02
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 (K020758)Pharmacia Deutschland GmbH2002-05-02
ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS (K020349)Axis-Shield Diagnostics, Ltd.2002-05-02
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS (K020348)Axis-Shield Diagnostics, Ltd.2002-05-02
QUANTA LITE CCP ELISA (K020414)Inova Diagnostics, Inc.2002-04-29
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM (K021103)Zeus Scientific, Inc.2002-04-24
QAB2A IGG ELISA KIT (K020695)Cheshire Diagnostics , Ltd.2002-04-19
QAB2A IGM ELISA KIT (K020694)Cheshire Diagnostics , Ltd.2002-04-19
MYALLERGYTEST SYSTEM (K020387)Immunetech Corporation2002-04-17
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (K011068)Rhigene, Inc.2002-04-11
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR (K013984)Diagnostic Products Corp.2002-03-28
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806)Bayer Corp.2002-03-27
QACA IGG/IGM ELISA KIT (K020241)Cheshire Diagnostics , Ltd.2002-03-13
LP(A)-LATEX SEIKEN ASSAY KIT (K013359)Denka Seiken'S2002-03-08
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T (K020156)Axis-Shield Diagnostics, Ltd.2002-03-06
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K012357)Bayer Diagnostics Corp.2002-02-28
TORFLEX TRANSSEPTAL GUIDING SHEATH (K013919)Baylis Medical Co., Inc.2002-02-22
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET (K014293)Kamiya Biomedical Co.2002-02-19
UROVYSION BLADDER CANCER RECURRENCE KIT (K013785)Vysis2002-02-08
CIC-C1Q EIA (K012576)American Laboratory Products Co., Ltd.2002-01-29
N LATEX LP(A) (K013128)Dade Behring, Inc.2002-01-18
WAMPOLE HS-CRP ELISA (K011855)Carter-Wallace, Inc.2002-01-08
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (K013956)Diamedix Corp.2002-01-08
NYCOCARD CRP CONTROL (K014084)Primus Corp.2002-01-07
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (K013304)Becton Dickinson Infusion Therapy Systems, Inc.2002-01-02
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (K013628)Diamedix Corp.2001-12-21
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K013568)Bayer Corp.2001-12-21
RAMP MYOGLOBIN ASSAY (K012040)Response Biomedical Corp.2001-12-18
GORE INTRODUCER SHEATH (K013282)W. L. Gore & Associates, Inc.2001-12-14
CONVOY ADVANCED DELIVERY SHEATH KIT (K013866)Boston Scientific2001-12-14
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM (K011244)Zeus Scientific, Inc.2001-12-10
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (K012337)Bayer Corp.2001-12-06
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT (K011958)Denka Seiken'S2001-12-04
TINA-QUANT COMPLEMENT C3C TEST SYSTEM (K012361)Roche Diagnostics Corp.2001-11-29
TINA-QUANT COMPLEMENT C4 TEST SYSTEM (K012359)Roche Diagnostics Corp.2001-11-29
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (K013432)Immuno Concepts, Inc.2001-11-29
TINA-QUANT APOLIPOPROTEIN VER.2 (K013249)Roche Diagnostics Corp.2001-11-16
TINA-QUANT APOLIPOPROTEIN B VER.2 (K013206)Roche Diagnostics Corp.2001-11-16
TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (K013278)Roche Diagnostics Corp.2001-11-15
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (K013285)Immuno Concepts, Inc.2001-11-14
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (K013283)Immuno Concepts, Inc.2001-11-14
TINA-QUANT APOLIPOPROTEIN B VER.2 (K013207)Roche Diagnostics Corp.2001-11-13
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (K012449)Diamedix Corp.2001-10-26
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (K012450)Diamedix Corp.2001-10-26
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS (K012777)Bayer Corp.2001-10-22
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) (K013135)Diagnostic Products Corp.2001-10-19
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) (K013134)Diagnostic Products Corp.2001-10-15
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT (K013080)Corgenix, Inc.2001-09-28
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT (K013079)Corgenix, Inc.2001-09-28
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (K012797)Diamedix Corp.2001-09-28
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (K012795)Diamedix Corp.2001-09-28
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT (K013077)Corgenix, Inc.2001-09-28
COLOR-MONOGEN (K012901)Instrumentation Laboratory CO2001-09-27
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT (K013018)Corgenix, Inc.2001-09-20
TINA-QUANT TRANSFERRIN VER.2 (K012371)Roche Diagnostics Corp.2001-09-19
TINA-QUANT TRANSFERRIN VER.2 (K012393)Roche Diagnostics Corp.2001-09-19
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 (K012208)Beckman Coulter, Inc.2001-09-07
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