Atlas FDA

Immunology

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

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RecordFirmDate
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (K911898)Reagents Applications, Inc.1991-05-08
ROCHE APOLIPOPROTEIN STANDARD (K910553)Roche Diagnostic Systems, Inc.1991-05-08
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST (K911849)General Biometrics, Inc.1991-05-07
IMMUNOWELL SM ANTIBODY TEST (K911851)General Biometrics, Inc.1991-05-07
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST (K911850)General Biometrics, Inc.1991-05-07
IMMUNOWELL RNP/SM ANTIBODY TEST (K911848)General Biometrics, Inc.1991-05-07
PHARMACIA SPECIFIC IGE CONTROL (K911631)Pharmacia, Inc.1991-04-24
ALLERGEN MODULES FOR ALASTAT TM (K894227)Diagnostic Products Corp.1991-04-17
ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED (K911511)Diagnostic Products Corp.1991-04-17
SYNCHRON C-REACTIVE PROTEIN REAGENT (K910535)Beckman Instruments, Inc.1991-04-12
NA ALPHA 1 MICROGLOBULIN KIT (K904254)Behring Diagnostics, Inc.1991-04-05
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) (K911175)Serono-Baker Diagnostics, Inc.1991-04-05
RHEUMAJET RF (K910539)Biokit USA, Inc.1991-04-05
MAST CLA ALLERGY SYSTEM (K910292)Mast Immunosystems1991-04-05
CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER (K905054)Ciba Corning Diagnostics Corp.1991-03-22
RHEUMAJET CRP (K910686)Biokit USA, Inc.1991-03-19
CIBA CORNING ACS FERRITIN IMMUNOASSAY (K905770)Ciba Corning Diagnostics Corp.1991-03-12
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK (K910082)Quidel Corp.1991-03-12
MILENIA BETA-2 MICROGLOBULIN (K910052)Diagnostic Products Corp.1991-03-06
HEMAGEN ENA SCREENING KIT (K910232)Hemagen Diagnostics, Inc.1991-03-06
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA (K910517)Pharmacia, Inc.1991-03-05
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY (K905612)Ventrex Laboratories, Inc.1991-02-21
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY (K905636)Ventrex Laboratories, Inc.1991-02-07
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE (K910075)Diagnostic Products Corp.1991-01-30
UBI MAGIWEL(TM) ANA QUANTITATIVE (K910033)United Biotech, Inc.1991-01-25
IMMUNOWELL THYROGLOBULIN TEST (K905485)General Biometrics, Inc.1991-01-25
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM (K905162)Quidel Corp.1991-01-14
IMMUNOWELL TPO (MICROSOME) TEST (K905486)General Biometrics, Inc.1991-01-03
TITAN GEL (K905149)Helena Laboratories1991-01-03
TURBIQUANT MYOGLOBIN (K905202)Behring Diagnostics, Inc.1990-12-13
DIASTAT ANTI-LA (SS-B) (K905193)Shield Diagnostics, Ltd.1990-12-13
DISTAT ANTI-DSDNA KIT (K905386)Shield Diagnostics, Ltd.1990-12-13
DIASTAT ANTI-RO (SS-A) (K905194)Shield Diagnostics, Ltd.1990-12-13
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN (K905176)Quidel Corp.1990-12-13
TURBO-RAST SPECIFIC IGE ASSAY (K904330)Ventrex Laboratories, Inc.1990-12-07
DIASTAT ANTI-SM (K905191)Shield Diagnostics, Ltd.1990-12-07
DIASTAT ANTI-SM/RNP (K905192)Shield Diagnostics, Ltd.1990-12-07
DIASTAT ENA PROFILE (K905190)Shield Diagnostics, Ltd.1990-12-07
ELEGANCE FERRITIN ELISA (K904822)Bioclone Australia Pty , Ltd.1990-11-29
IVT RAST TRACER (K904661)In Vitro Technologies, Inc.1990-11-29
ALRGN SET (K903637)Ciba Corning Diagnostics Corp.1990-11-21
UC IMU B (K904137)Eucardio Laboratory, Inc.1990-11-21
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (K904175)Reagents Applications, Inc.1990-11-13
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST (K904497)Biotrax, Inc.1990-11-01
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST (K904498)Biotrax, Inc.1990-10-29
TURBIQUANT MYOGLOBIN (K903687)Behring Diagnostics, Inc.1990-10-16
V-TREND TARGET RF TEST (K904105)Texas Immunology, Inc.1990-10-15
ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE (K903742)Diagnostic Products Corp.1990-10-15
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL (K903738)Quidel Corp.1990-10-15
NOVA LITE TM THYROID (K904224)Inova Diagnostics, Inc.1990-10-15
IMMUNODOT THYROID AUTOIMMUNITY PANEL (K903843)General Biometrics, Inc.1990-10-02
RHEUMAGEN CRP T-CONTROL (K904312)Biokit USA, Inc.1990-10-01
LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM (K903215)Bioproducts For Science, Inc.1990-09-25
UC IMU A (K904125)Eucardio Laboratory, Inc.1990-09-24
MYOGLOBIN RIA TEST KIT (K904038)Immuno Diagnostic Center, Inc.1990-09-24
C3C AND C4 RID KITS (K902382)The Binding Site, Ltd.1990-09-07
ANTI-SCI-70 MICROASSAY (K902915)Diamedix Corp.1990-09-06
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL (K902220)Boehringer Mannheim Corp.1990-09-05
QUANTA LITE TM DSDNA (K903898)Inova Diagnostics, Inc.1990-09-05
ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA (K902576)Diagnostic Products Corp.1990-09-04
RAPITEX (R) CRP NEW (K903853)Behring Diagnostics, Inc.1990-08-30
RAPITEX(R) RF NEW (K903852)Behring Diagnostics, Inc.1990-08-30
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT (K896918)Dako Corp.1990-08-27
PHARMACIA DELFIA SYSTEM B2-MICRO (K903578)Pharmacia, Inc.1990-08-17
ANTI-SCI-70 ANTIBODY TEST (K903314)Immco Diagnostics, Inc.1990-08-14
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 (K902938)General Biometrics, Inc.1990-08-09
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 (K903047)General Biometrics, Inc.1990-08-09
LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (K903195)London Diagnostics, Inc.1990-08-02
MILENIA (TM) FERRITIN (K902997)Diagnostic Products Corp.1990-08-02
EQUATE(TM) AQR APO AL/B DUO CONTROL (K903122)Binax, Inc.1990-08-02
TURBO-RAST SPECIFIC IGE ASSAY (K903000)Ventrex Laboratories, Inc.1990-07-31
CARDS O.S. MONO (K902510)Pacific Biotech, Inc.1990-07-16
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE (K902897)United Biotech, Inc.1990-07-16
TENONE(TM) OPIATES CATALOG: VKSO1,4 (K902055)Diagnostic Products Corp.1990-07-10
MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT (K902237)Medica Corp.1990-07-09
RAICHEM(TM) SPIA(TM) CRP REAGENT (K902593)Reagents Applications, Inc.1990-06-28
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX (K902541)Trinity Laboratories, Inc.1990-06-28
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) (K902484)Beckman Instruments, Inc.1990-06-21
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) (K902485)Beckman Instruments, Inc.1990-06-21
MODIFIED QM300 RHEUMATOID FACTOR TEST (K902462)Kallestad Diag, A Div. of Erbamont, Inc.1990-06-21
BEHRING LASER NEPHELOMETER (K761234)Behring Diagnostics, Inc.1990-06-07
REP(R) IMMUNOFIX (K901805)Helena Laboratories1990-06-06
NA LATEX MYOGLOBIN TEST (K902154)Behring Diagnostics, Inc.1990-06-01
HEMAGEN ENA [JO-I] KIT (K902139)Hemagen Diagnostics, Inc.1990-05-18
READS(R) ANTI-ENA (SM/RNP) TEST KIT (K901924)Biosearch Medical Products, Inc.1990-05-09
COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 (K901859)Diagnostic Products Corp.1990-05-03
NOVA LITE(TM) ANA KSL (K901596)Inova Diagnostics, Inc.1990-05-02
APOLIPOPROTEIN A-I (APO A-I) (K901675)Sigma Chemical Co.1990-04-26
MODIFIED TECHNICON DPA-1(TM) SYSTEM (K900943)Technicon Instruments Corp.1990-04-26
NOVA LITE(TM) ANA MK (K901595)Inova Diagnostics, Inc.1990-04-26
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD (K901453)Isolab, Inc.1990-04-12
BETA-2 MICROGLOBULIN EIA (K901333)Serex, Inc.1990-04-02
LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. (K901075)London Diagnostics, Inc.1990-04-02
REAADS ANTI-SM TEST KIT (K901230)Biosearch Medical Products, Inc.1990-03-23
ANTI-RNP MICROASSAY (K901073)Diamedix Corp.1990-03-19
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT (K900875)Reagents Applications, Inc.1990-03-06
APOLIPOPROTEIN B (APO B) (K900124)Sigma Chemical Co.1990-03-02
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 (K900422)Helena Laboratories1990-02-27
AIA-PACK BMG (K900440)Tosoh Medics, Inc.1990-02-26
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET (K900625)Armkel, LLC1990-02-26
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