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Immunology

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

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RecordFirmDate
WAKO AUTOKIT RF (K922151)Wako Chemicals USA, Inc.1992-07-28
SYNELISA TPO ANTIBODIES (K921787)Elias U.S.A., Inc.1992-07-28
VENTREX ALLERGEN DISC (K922538)Hycor Biomedical, Inc.1992-07-27
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY (K922125)Baxter Diagnostics, Inc.1992-07-21
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL (K922387)Baxter Diagnostics, Inc.1992-07-15
DIASTAT ANTI-HISTONE KIT (K920616)Shield Diagnostics, Ltd.1992-07-14
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST (K922296)Ampcor, Inc.1992-07-14
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST (K922297)Ampcor, Inc.1992-07-14
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT (K921183)Shield Diagnostics, Ltd.1992-06-19
COBAS CORE FERRITIN EIA (K920829)Roche Diagnostic Systems, Inc.1992-06-19
IL TEST IMMUNOGLOBULIN A (K920014)Instrumentation Laboratory CO1992-06-16
IL TEST COMPLEMENT 3 (K920007)Instrumentation Laboratory CO1992-06-16
SYNELISA CARDIOLIPIN ANTIBODIES (K921250)Elias U.S.A., Inc.1992-06-04
CEDIA FERRITIN ASSAY (K920318)Microgenics Corp.1992-06-04
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT (K920132)Elias U.S.A., Inc.1992-05-28
IGG SUCLASS EIA (K921575)Virotech Diagnostika1992-05-28
THE THERATEST EL-ANA PROFILES (K914454)Theratest Laboratories, Inc.1992-05-22
DAB DETECTION KIT (K920600)Ventana Medical Systems, Inc.1992-05-11
AEC DETECTION KIT (K920566)Ventana Medical Systems, Inc.1992-05-08
AUTOSTAT(TM) ANTI-DSNA (K913342)Cogent Diagnotics , Ltd.1992-05-01
SYNELISA TGAB (K915134)Elias U.S.A., Inc.1992-04-08
ACS TOTAL IGE IMMUNOASSAY (K920372)Ciba Corning Diagnostics Corp.1992-04-08
SYNELISA TMAB (K915133)Elias U.S.A., Inc.1992-04-08
SYNELISA TGAB/TMAB (K915135)Elias U.S.A., Inc.1992-04-08
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY (K920952)Vitek Systems, Inc.1992-04-07
HEMAGEN ENA [JO-1] KIT (EIA METHOD) (K915420)Hemagen Diagnostics, Inc.1992-04-07
KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT (K915429)Kronus1992-03-30
ANTI-ENA ANTIBODY TEST (SM) (K920385)Immco Diagnostics, Inc.1992-03-30
RF STAT IGM TEST KIT (K920753)Biowhittaker Molecular Applications, Inc.1992-03-30
KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT (K915428)Kronus1992-03-30
ANTI-ENA ANTIBODY TEST [SS-A (RO)] (K920383)Immco Diagnostics, Inc.1992-03-30
MYOGLOBIN RIA TEST KIT (K915233)Pro Diagnostics, Inc.1992-03-30
ANIT-ENA ANTIBODY TEST [SS-B (LA)] (K920384)Immco Diagnostics, Inc.1992-03-30
ANTI-ENA ANTIBODY TEST KIT (K920386)Immco Diagnostics, Inc.1992-03-30
HUMAN IGG SUBCLASS RID KIT (K915650)Janssen Biochimica1992-03-26
OPUS FERRITIN TEST SYSTEM (K915838)Pb Diagnostic Systems, Inc.1992-03-18
ENCORE SCL-70 (K920150)Clark Laboratories, Inc.1992-03-18
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) (K915508)Diagnostic Systems Laboratories, Inc.1992-03-17
OPUS MYOGLOBIN TEST SYSTEM (K915850)Pb Diagnostic Systems, Inc.1992-03-17
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) (K915272)Hemagen Diagnostics, Inc.1992-03-17
B2-MICROGLOBULIN RADIOIMMUNOASSAY (K920300)Nichols Institute1992-03-17
SPECIFIC IGE EIA-TURBO ASSAY (K914554)Ventrex Laboratories, Inc.1992-03-13
IL TEST COMPLEMENT 4 (K920010)Instrumentation Laboratory CO1992-03-13
HEALTHTEST RHEUMATOID FACTOR ASSAY (K920220)Akers Research Corp.1992-03-13
IL TEST IMMUNOGLOBULIN G (IGG) (K920006)Instrumentation Laboratory CO1992-03-13
HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY (K920221)Akers Research Corp.1992-03-13
IL TEST IMMUNOGLOBULIN M (IGM) (K920008)Instrumentation Laboratory CO1992-03-11
ISOTYPES HUMAN IGG SUBCLASS EIA KIT (K920370)Isotypes, Inc.1992-03-11
TURBIQUANT (K920124)Behring Diagnostics, Inc.1992-03-02
VENTREX ALLERGEN DISC (K913833)Ventrex Laboratories, Inc.1992-02-21
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K915282)Hemagen Diagnostics, Inc.1992-02-12
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM (K914550)Diagnostic Resources, Inc.1992-02-11
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT (K920046)Medix Biotech, Inc.1992-01-28
IL TEST(TM) TRANSFERRIN (TRF) (K914993)Instrumentation Laboratory CO1992-01-17
COMPLEMENT C1 INACTIVATOR KIT (K915431)The Binding Site, Ltd.1992-01-17
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT (K914853)Reads Medical Products, Inc.1992-01-15
TIA CRP TEST KIT (K914155)Crestat Diagnostics, Inc.1992-01-15
ALPHA-2 MACROGLOBULIN TEST RID KIT (K914389)The Binding Site, Ltd.1991-12-20
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) (K915234)Hemagen Diagnostics, Inc.1991-12-20
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT (K913668)The Binding Site, Ltd.1991-12-20
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K915058)Hemagen Diagnostics, Inc.1991-12-20
PREALBUMIN IMMUNOLOGICAL NL TEST KIT (K913672)The Binding Site, Ltd.1991-12-20
READS(R) IGA ANTI-CARDIOLIPIN TEST KIT (K914405)Reads Medical Products, Inc.1991-12-18
ALBUMIN TEST RID KIT (K914391)The Binding Site, Ltd.1991-12-10
TRANSFERRIN RID KIT (K914390)The Binding Site, Ltd.1991-12-09
HAPTOGLOBIN IMMUNOLOGICAL TEST KIT (K913670)The Binding Site, Ltd.1991-12-09
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT (K913666)The Binding Site, Ltd.1991-12-09
CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE (K914850)Mast Immunosystems1991-12-09
IMMUNOWELL DSDNA ANTIBODY TEST (K914801)General Biometrics, Inc.1991-12-09
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM (K911661)Immuno Concepts, Inc.1991-12-09
HUMAN IGD IMMUNOLOGICAL NL TEST KIT (K913671)The Binding Site, Ltd.1991-12-02
ABBOTT MATRIX AERO PLUS SYSTEM (K913150)Abbott Laboratories1991-11-29
3M ANTI-CARDIOLIPIN FAST(TM) TEST (K913054)3M Diagnostic Systems, Inc.1991-11-27
3M IGE SINGLE POINT FAST TEST (K913212)Whittaker Bioproducts, Inc.1991-11-22
ALLERGY INFORMATION MANAGER (K912294)Diagnostic Products Corp.1991-11-22
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR (K914225)E.I. Dupont DE Nemours & Co., Inc.1991-11-22
QUANTA LITE(TM) ACA (K911680)Inova Diagnostics, Inc.1991-11-19
3M ANTI-DSDNA FAST TEST (K913653)3M Diagnostic Systems, Inc.1991-11-07
HUMAN BETA-2 MICROGLOBIN EN-RID KIT (K913131)The Binding Site, Ltd.1991-11-07
ANTI-DSDNA ANTIBODY TEST (K913041)Helix Diagnostics, Inc.1991-11-05
C1 RID KIT (K914388)The Binding Site, Ltd.1991-10-28
FASTTECH SYSTEM II (K913892)3M Diagnostic Systems, Inc.1991-10-02
ANTI-JO-1 MICROASSAY (K911679)Diamedix Corp.1991-09-23
ANTI-DNA MICROASSAY (K912020)Diamedix Corp.1991-09-23
ANTI-GBM ANTIBODIES QUANTITATIVE KIT (K904181)Biochemical Diagnostic, Inc.1991-09-10
DSL BETA 2 MICROGLOBULIN (DSL 6200) (K911881)Diagnostic Systems Laboratories, Inc.1991-09-10
DSL BETA 2 MICROGLOBULIN (DSL 6100) (K912173)Diagnostic Systems Laboratories, Inc.1991-08-13
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA (K911903)Pharmacia, Inc.1991-08-12
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K912582)Ciba Corning Diagnostics Corp.1991-07-31
DISTAT ANTI-SCL-70 KIT (K912291)Shield Diagnostics, Ltd.1991-07-30
DIASTAT ANTI-JO-1 KIT (K912292)Shield Diagnostics, Ltd.1991-07-30
KALLESTEAD TOTAL IGE MICROPLATE KIT (K912800)Bio-Rad Laboratories, Inc.1991-07-25
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA (K912940)Diagnostic Products Corp.1991-07-24
HUMAN C-REACTIVE PROTEIN RID KIT (K905633)The Binding Site, Ltd.1991-07-22
BIOCLONE'S ELEGANCE IGE ELISA KIT (K910419)Bioclone Australia Pty , Ltd.1991-06-21
ELISA COMBI-KIT HUMAN IGG SUBCLASSES (K911610)Janssen Research Foundation1991-06-12
RHEUMAGEN RF T-CONTROL (K904310)Biokit USA, Inc.1991-05-31
NATIVE PROTHROMBIN ANTIGEN EIA (K910617)Organon Teknika Corp.1991-05-15
RAICHEM SPIA C3 REAGENT (K911900)Reagents Applications, Inc.1991-05-09
RAICHEM SPIA C4 REAGENT (K911899)Reagents Applications, Inc.1991-05-09
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