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Immunology

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

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RecordFirmDate
SERATEST ENA [SSA] KIT (K900617)Hemagen Diagnostics, Inc.1990-02-23
3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 (K900108)3M Company1990-02-21
3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 (K900244)3M Company1990-02-21
PHARMACIA B2 MICRO EIA (K900449)Pharmacia, Inc.1990-02-05
ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY (K900241)Diamedix Corp.1990-02-02
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS (K896926)Quidel Corp.1990-01-26
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 (K900072)General Biometrics, Inc.1990-01-24
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA (K894190)Pharmacia, Inc.1990-01-22
TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT (K900167)Behring Diagnostics, Inc.1990-01-22
LD-1 (K900107)Boehringer Mannheim Corp.1990-01-18
ENZYMUN TEST R IGE (K896902)Boehringer Mannheim Corp.1990-01-10
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8) (K897145)3M Company1990-01-10
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM (K897025)Zeus Scientific, Inc.1990-01-02
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (K896852)Ventrex Laboratories, Inc.1989-12-18
VENTREZYME VAST SPECIFIC IGE ASSAY (K896694)Ventrex Laboratories, Inc.1989-12-08
IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 (K896347)General Biometrics, Inc.1989-12-05
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY (K896592)Ciba Corning Diagnostics Corp.1989-12-04
MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT (K896585)Medix Biotech, Inc.1989-12-04
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK (K896483)Kallestad Diag, A Div. of Erbamont, Inc.1989-12-01
NOVA GEL(TM) T SM/RNP (K896459)Inova Diagnostics, Inc.1989-11-20
NOVA GEL(TM) T SS-A/SS-B (K896460)Inova Diagnostics, Inc.1989-11-20
NOVA GEL(TM) T SCL-70 (K896461)Inova Diagnostics, Inc.1989-11-20
NOVA GEL(TM) T JO-1 (K896462)Inova Diagnostics, Inc.1989-11-20
ABBOTT IMX IGE (K895914)Abbott Laboratories1989-11-13
HUMAN (IGG) SUBCLASS (EIA) KIT (K895600)The Binding Site, Ltd.1989-11-08
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (K896271)Biokit USA, Inc.1989-11-08
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (K896272)Biokit USA, Inc.1989-11-08
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES (K895996)Lipogen, Inc.1989-11-06
MODIFIED QM300 ALBUMIN ANTIBODY PACK (K896059)Kallestad Diag, A Div. of Erbamont, Inc.1989-11-06
RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES (K895997)Lipogen, Inc.1989-11-06
LEECO PREVIEW(R) EBV (EIA) (K895765)Leeco Diagnostics, Inc.1989-10-31
DETECTADOT SYSTEM 2000 HETEROPHILE TEST (K895891)Gull Laboratories, Inc.1989-10-31
RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES (K895995)Lipogen, Inc.1989-10-27
RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES (K895994)Lipogen, Inc.1989-10-24
ANTI-RNP AND ANTI-SM ANTIBODY TEST (K895338)Immco Diagnostics, Inc.1989-10-17
LAN.0800Q/2800Q (K895872)Amersham Corp.1989-10-17
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA (K895496)Incstar Corp.1989-10-17
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN (K895808)Technicon Instruments Corp.1989-10-17
ORTHO *APO A-1 ELISA TEST SYSTEM (K895160)Medical Marketing Consultants, Inc.1989-10-06
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST (K895339)Immco Diagnostics, Inc.1989-10-04
MILENIA(TM) TOTAL IGE (MKIE1,5) (K895004)Diagnostic Products Corp.1989-09-28
WAKO(TM) AUTOKIT CRP (K895598)Wako Chemicals USA, Inc.1989-09-27
QM300 CERULOPLASMIN ANTIBODY PACK (K895377)Kallestad Diag, A Div. of Erbamont, Inc.1989-09-21
PROGENE IGE BEAD EIA (K895294)Progene Corp.1989-09-21
ANA ANTISERA CONTROL KIT (K894659)Lipogen, Inc.1989-09-21
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST (K894975)General Biometrics, Inc.1989-09-13
ADX TM OPIATES (K890689)Abbott Laboratories1989-08-25
ANTI-SM MICROASSAY (K894894)Diamedix Corp.1989-08-24
MONODEX (K894793)Cenogenics Corp.1989-08-21
TECHNICON DPA-1 SYSTEM RF METHOD (K894574)Technicon Instruments Corp.1989-08-10
SCANLISA HUMAN CRP ELISA KIT (K894573)Immuntech A/S1989-08-10
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK (K894538)Kallestad Diag, A Div. of Erbamont, Inc.1989-08-04
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) (K893419)Coulter Immunology1989-08-03
SERATEST ENA [SCL-70] KIT (K894411)Hemagen Diagnostics, Inc.1989-08-02
RAICHEM(TM) SPIA(TM) IGA REAGENTS (K894418)Reagents Applications, Inc.1989-08-02
RAICHEM(TM) SPIA(TM) IGM REAGENTS (K894417)Reagents Applications, Inc.1989-08-02
RAICHEM(TM) SPIA(TM) IGG REAGENTS (K894416)Reagents Applications, Inc.1989-08-01
QUIDEL FOOD ALLERGEN SCREEN (K894253)Quidel Corp.1989-07-28
ANTI-THYROGLOBULIN TEST KIT (K894203)Kronus1989-07-25
MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (K894364)Kronus1989-07-25
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION (K894039)Quidel Corp.1989-07-14
QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA (K893896)Biostar Medical Products, Inc.1989-07-14
PHARMACIA CAP SYSTEM IGE RIA AND FEIA (K893951)Pharmacia, Inc.1989-07-14
SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM (K893897)Biostar Medical Products, Inc.1989-06-23
BACTON TM, BASIC TM, APO A-I REAGENT (K893885)Catachem, Inc.1989-06-21
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST (K893737)Quidel Corp.1989-06-16
BECKMAN EPSILON(TM) IGE REAGENT KIT (K893125)Beckman Instruments, Inc.1989-06-16
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 (K892424)Helena Laboratories1989-06-09
REAADS-RF TEST KIT-SEMIQUANTITATIVE (K892445)Biosearch Medical Products, Inc.1989-06-05
REAADS-RF TEST KIT-QUANTITATIVE (K892444)Biosearch Medical Products, Inc.1989-06-05
ALATOP (TM) CATALOG # AKAL1 (K892197)Diagnostic Products Corp.1989-06-02
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) (K893036)Amersham Corp.1989-06-02
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC (K893132)Pharmacia, Inc.1989-06-02
NOVA GEL(TM) JO-1 (K892897)Inova Diagnostics, Inc.1989-05-17
PHADIATOP PAEDIATRIC RIA AND EIA (K891135)Pharmacia, Inc.1989-05-09
SPQ TM TEST SYSTEM II FOR CRP (K892526)Atlantic Antibodies1989-05-09
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST (K892421)Lipogen, Inc.1989-05-09
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) (K892362)Amersham Corp.1989-05-09
TECHNICON DPA-1 (TM) CRP METHOD (K892198)Technicon Instruments Corp.1989-05-09
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN (K892409)Quidel Corp.1989-05-04
BEHRING NEPHELOMETER 100 (K892223)Behring Diagnostics, Inc.1989-05-04
ACA (R) DIGITOXIN CALIBRATOR (K891093)E.I. Dupont DE Nemours & Co., Inc.1989-04-26
V-TREND TARGET CRP TEST (K892231)Texas Immunology, Inc.1989-04-21
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (K891385)Vitek Systems, Inc.1989-04-18
EZ COMPLEMENT C3 (K892127)Diamedix Corp.1989-04-14
ANA-5 AUTOANTIBODY PROFILE KIT (K885224)Autoimmunity Diagnostics Corp.1989-04-14
C REACTIVE PROTEIN LIQUID (K892146)Ampcor, Inc.1989-04-14
EZ COMPLEMENT C2 (K892125)Diamedix Corp.1989-04-14
EZ COMPLEMENT C4 (K892129)Diamedix Corp.1989-04-14
EZ COMPLEMENT C1 (K891904)Diamedix Corp.1989-04-14
QUIK-DOT C REACTIVE PROTEIN (K892119)Ampcor, Inc.1989-04-14
TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (K891683)Helena Laboratories1989-04-12
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) (K890530)Behring Diagnostics, Inc.1989-03-27
TITAN GEL IFE TRIVALENT ANTISERUM (K891188)Helena Laboratories1989-03-22
ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) (K891098)Immco Diagnostics, Inc.1989-03-22
MID-LEVEL IGG KIT CAT. NO. 9315 (K891299)Helena Laboratories1989-03-22
ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) (K891099)Immco Diagnostics, Inc.1989-03-22
RIA-GNOST FERRITIN (K890697)Cambridge Medical Technology1989-03-16
BETA-2 MICROGLOBULIN EIA (K890694)Serex, Inc.1989-03-16
MONO-CUBE(TM) (K890991)Difco Laboratories, Inc.1989-03-16
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