Atlas FDA

Immunology

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

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RecordFirmDate
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY (K954814)Orgentec1996-04-18
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY (K954829)Orgentec1996-04-18
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY (K954815)Orgentec1996-04-18
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY (K954832)Orgentec1996-04-18
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (K953495)Scimedx Corp.1996-04-10
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (K955794)Randox Laboratories, Ltd.1996-04-05
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR (K955798)Randox Laboratories, Ltd.1996-04-05
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR (K955797)Randox Laboratories, Ltd.1996-04-05
HYTEC AUTOIMMUNE KITS (RNP) (K954897)Hycor Biomedical, Inc.1996-03-22
ANTI-KERATIN-HMW PRIMARY ANTI-BODY (K941173)Ventana Medical Systems, Inc.1996-03-22
HYTEC AUTOIMMUNE KITS (SM) (K954896)Hycor Biomedical, Inc.1996-03-22
RETINOL BINDING RID KIT (K955881)The Binding Site, Ltd.1996-03-22
KERATIN PRIMARY ANTIBODY (K935161)Ventana Medical Systems, Inc.1996-03-22
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM (K960182)Mardx Diagnostics, Inc.1996-03-20
HYTEC AUTOIMMUNE KITS (SCL-70) (K954894)Hycor Biomedical, Inc.1996-03-20
ORGENTEC ENASCREEN ELISA ASSAY (K955134)Orgentec1996-03-20
ORGENTEC ENASCREEN PIN IMMUNO ASSAY (K955133)Orgentec1996-03-20
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT (K960091)Helix Diagnostics, Inc.1996-03-20
HYTEC AUTOIMMUNE KIT (JO-1) (K954895)Hycor Biomedical, Inc.1996-03-20
HYTEC AUTOMIMMUNE KIT (DS-DNA) (K954893)Hycor Biomedical, Inc.1996-03-20
QUANTA LITE PR3 (K955021)Inova Diagnostics, Inc.1996-03-19
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES (K954105)Scimedx Corp.1996-03-19
QUANTA LITE MPO (K955022)Inova Diagnostics, Inc.1996-03-19
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES (K954062)Scimedx Corp.1996-03-19
HEMAGEN CRP 150 KIT (EIA METHOD) (K960324)Hemagen Diagnostics, Inc.1996-03-12
THERATEST KIT (MODIFICATION) (K955481)Theratest Laboratories, Inc.1996-03-06
QUANTA LITE SSDNA (K954380)Inova Diagnostics, Inc.1996-02-29
CHEMMATE SPECIAL STAIN LCA-CD45 (K936111)Biotek Solutions, Inc.1996-02-27
KERATIN PRIMARY ANTIBODY (K940331)Ventana Medical Systems, Inc.1996-02-26
N PROTEIN STANDARS SY (K955857)Behring Diagnostics, Inc.1996-02-21
WAKO AUTOKIT CRP NEW (K955156)Wako Chemicals USA, Inc.1996-02-16
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT (K954537)Olympus America, Inc.1996-02-14
IMMILITE TOTAL IGE (K960067)Diagnostic Products Corp.1996-02-14
BOEHRINGER MANNHEIM IGG ASSAY (K955906)Boehringer Mannheim Corp.1996-02-09
CARDIOLIPIN IGG EIA TEST KIT (K952523)Immunoprobe, Inc.1996-02-09
BOEHRINGER MANNHEIM IGM ASSAY (K955908)Boehringer Mannheim Corp.1996-02-09
CARDIOLIPIN IGM EIA TEST SYSTEM (K952521)Immunoprobe, Inc.1996-02-09
BOEHRINGER MANNHEIM IGA ASSAY (K955907)Boehringer Mannheim Corp.1996-02-09
CARDIOLIPIN IGA EIA TEST SYSTEM (K952522)Immunoprobe, Inc.1996-02-09
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT (K946069)The Binding Site, Ltd.1996-01-30
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT (K946070)The Binding Site, Ltd.1996-01-30
PHARMACIA CAP SYSTEM PHADIATOP FEIA (K941993)Pharmacia, Inc.1996-01-30
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT (K946068)The Binding Site, Ltd.1996-01-30
VARELISA MPO-ANCA (K953587)Elias U.S.A., Inc.1996-01-26
VARELISA PR3-ANCA (K953586)Elias U.S.A., Inc.1996-01-26
CARDIOLIPIN M EIA TEST SYSTEM (K946217)Hogan & Hartson1996-01-24
CARDIOLIPIN G EIA TEST SYSTEM (K946215)Hogan & Hartson1996-01-24
CARDIOLIPIN A EIA TEST SYSTEM (K946216)Hogan & Hartson1996-01-24
HYTEC AUTOIMMUNE KIT (SS-A) (K954392)Hycor Biomedical, Inc.1995-12-26
HYTEC AUTOIMMUNE KITS (SS-B) (K954891)Hycor Biomedical, Inc.1995-12-26
HYTEC AUTOMMUNE KIT (ENA) (K954890)Hycor Biomedical, Inc.1995-12-26
HYTEC AUTOMIMMUNE KIT (RF) (K954892)Hycor Biomedical, Inc.1995-12-26
WAKO AUTOKIT APO B (K954657)Wako Chemicals USA, Inc.1995-12-20
TEST, RHEUMATOID FACTOR (K955086)Polymedco, Inc.1995-12-20
REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT (K952287)Reaads Medical Products, Inc.1995-12-18
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM (K954566)Diagnostic Products Corp.1995-12-18
C-REACTIVE PROTEIN LATEX KIT (K954447)Randox Laboratories, Ltd.1995-12-18
WAKO AUTOKIT CH50 (K954145)Wako Chemicals USA, Inc.1995-12-18
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (K954723)Helix Diagnostics, Inc.1995-12-15
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (K954700)Helix Diagnostics, Inc.1995-12-15
IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM (K952490)Roche Image Analysis Systems1995-12-15
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM (K955042)Shared Systems, Inc.1995-12-13
CHEMMATE(TM) LAMBDA (K950149)Biotek Solutions, Inc.1995-12-06
ANTI-TPO (K954256)Biomerica, Inc.1995-11-27
THYROGLOBULIN EIA TEST KIT (K951362)Immunoprobe, Inc.1995-11-20
MICROSOMAL EIA TEST KIT (K951364)Immunoprobe, Inc.1995-11-20
ACCESS ALLERGEN DOG EPITHELIM (K953780)Bio-Rad Laboratories, Inc.1995-11-14
THERATEST LAB, INC., EL-ANASCR KIT (K954106)Theratest Laboratories, Inc.1995-11-14
ORGEN TEC ANTI-DSDNA ELISA ASSAY (K953671)Orgentec1995-11-09
VENTANA BLUE DETECTION KIT (K940424)Ventana Medical Systems, Inc.1995-11-06
CHEMMATE(TM) UCHL1 (CD45-RO) (K950152)Biotek Solutions, Inc.1995-10-27
CHEMMATE(TM) KAPPA (K950150)Biotek Solutions, Inc.1995-10-27
CARDIOLIPIN IGG,M,A EIA TEST SYSTEM (K951363)Immunoprobe, Inc.1995-10-13
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (K951639)Incstar Corp.1995-10-13
CHEMMATE(TM) L26 (CD20) (K950151)Biotek Solutions, Inc.1995-10-04
QUICKVUE ONE-STEP ALLERGEN SCREEN (K950728)Quidel Corp.1995-10-02
VARELISA CARDIOLIPIN ABS SCREEN (K951187)Elias U.S.A., Inc.1995-10-02
ACCESS MYOGLOBIN REAGENTS (K951634)Bio-Rad Laboratories, Inc.1995-09-27
THERATEST EL-ANA PROFILES TEST SYSTEM (K950716)Theratest Laboratories, Inc.1995-09-26
LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953926)International Enzymes, Inc.1995-09-15
CARDIOLIPIN IGG,M,A EIA TEST KIT (K952520)Immunoprobe, Inc.1995-09-15
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM (K953927)International Enzymes, Inc.1995-09-15
QUANTA LITE IGA ACA (HRP) (K953366)Inova Diagnostics, Inc.1995-09-01
QUANTA LITE ACA SCREEN (HRP) (K953291)Inova Diagnostics, Inc.1995-08-29
AURAFLEX TG-AB AND TPO-AB (K951320)Organon Teknika Corp.1995-08-25
AURAFLEX TPO-AB (K952607)Organon Teknika Corp.1995-08-25
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT (K952253)Helix Diagnostics, Inc.1995-08-24
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT (K953520)Olympus America, Inc.1995-08-24
HUMAN C5 RID KITS (K942326)Jay H. Geller1995-08-24
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN (K953014)Diagnostic Products Corp.1995-08-15
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM (K953261)Shared Systems, Inc.1995-08-15
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN (K952360)Princeton BioMeditech Corp.1995-08-14
SERODIA ATG (K953066)Fujirebio America, Inc.1995-08-14
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) (K953207)The Binding Site, Ltd.1995-08-01
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) (K953197)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-31
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR (K953212)Randox Laboratories, Ltd.1995-07-31
EL-RF/3 (IGM-IGG-IGA) KIT (K941398)Theratest Laboratories, Inc.1995-07-28
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (K951850)Helix Diagnostics, Inc.1995-07-18
QUANTA LITE ACA IGM (HRP) (K946385)Inova Diagnostics, Inc.1995-07-18
QUANTA LITE(TM) IGG (HRP) (K946034)Inova Diagnostics, Inc.1995-07-18
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