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Immunology

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

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RecordFirmDate
ELISA-DPXA SSA KIT (K924945)Advanced Biological Products, Inc.1993-05-19
ELISA-DOXA SCL-70 (K924949)Advanced Biological Products, Inc.1993-05-19
ELISA-DOXA JO-1 (K924950)Advanced Biological Products, Inc.1993-05-19
VENTREX ALLERGEN DISC (K925044)Ventrex, Inc.1993-05-14
THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT (K931311)Nichols Institute1993-05-14
SYNELISA SM ABS/RNP-SM ABS (K930141)Elias U.S.A., Inc.1993-05-11
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES (K930142)Elias U.S.A., Inc.1993-05-11
AYNELISA M2-ANTIBODIES (K930143)Elias U.S.A., Inc.1993-05-11
TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (K931247)Helena Laboratories1993-04-27
THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT (K930777)Nichols Institute1993-04-08
SYNELISA JO-1 ANTIBODIES (K930281)Elias U.S.A., Inc.1993-04-06
IMMUNO RA UNDILUTED (K926569)Immunostics Co., Inc.1993-04-06
SYNELISA SCL-70 ANTIBODIES (K930417)Elias U.S.A., Inc.1993-04-06
RHEUMELISA II JO-1 ANTIBODY TEST KIT (K930757)Biowhittaker Molecular Applications, Inc.1993-03-26
RHEUMELISA II SCL-70 ANTIBODY TEST KIT (K930130)Biowhittaker Molecular Applications, Inc.1993-03-23
ANTI-DSDNA ANTIBODY TEST (K921658)Immco Diagnostics, Inc.1993-03-22
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET (K924857)Tosoh Medics, Inc.1993-03-18
QUANTA LITE(TM) THYROID M ELISA (K930485)Inova Diagnostics, Inc.1993-03-16
QUANTA LITE(TM) THYROID T ELISA (K930486)Inova Diagnostics, Inc.1993-03-15
TINA-QUANT CRP (K930621)Boehringer Mannheim Corp.1993-03-10
HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (K930247)The Binding Site, Ltd.1993-03-10
ELIAS DSDNA ABS (K930421)Elias U.S.A., Inc.1993-03-10
QUANTA LITE(TM) JO-1 ELISA KIT (K926562)Inova Diagnostics, Inc.1993-03-04
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY (K923420)Ciba Corning Diagnostics Corp.1993-02-23
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC (K924769)The Binding Site, Ltd.1993-02-23
BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST (K925183)Princeton Biomedix1993-02-23
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME (K930274)Joldon Diagnostics1993-02-23
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC (K924767)The Binding Site, Ltd.1993-02-23
IL TEST CALIBRATION SET APO A1B (K923079)Instrumentation Laboratory CO1993-02-05
THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT (K925194)Joldon Diagnostics1993-02-05
PSA ANTIBODY KIT (K924578)Ventana Medical Systems, Inc.1993-02-05
PAP ANTIBODY KIT (K924629)Ventana Medical Systems, Inc.1993-02-04
EN TYPING CIE KIT FOR DIAGNOSTIC USE (K925118)The Binding Site, Ltd.1993-02-02
ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA (K925826)Clark Laboratories, Inc.1993-01-26
AUTOSTAT ANTITHYROGLOBIN (K925784)Cogent Diagnotics , Ltd.1993-01-21
AUTOSTAT ANTI-THYROID MICROSOMAL KIT (K925785)Cogent Diagnotics , Ltd.1993-01-21
SPECIFIC IGE EIA-TURBO ASSAY (K925425)Hycor Biomedical, Inc.1993-01-14
ELIAS TGAB (K925922)Elias U.S.A., Inc.1993-01-14
ELIAS TMAB (K925923)Elias U.S.A., Inc.1993-01-14
ACCESS FERRITIN ASSAY (K926221)Bio-Rad Laboratories, Inc.1993-01-13
IMMULITE FERRITIN (K925848)Diagnostic Products Corp.1993-01-13
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE (K924262)The Binding Site, Ltd.1992-12-29
LPIA-FERRITIN ASSAY (K924186)Seradyn, Inc.1992-12-23
ENCORE DS-DNA (K923537)Clark Laboratories, Inc.1992-12-23
AIA-PACK FER CALIBRATION VERIFICATION TEST SET (K924858)Tosoh Medics, Inc.1992-12-15
QUANTA LITE(TM) SCL-70 ELISA (K924898)Inova Diagnostics, Inc.1992-12-15
ZORBA(TM) IGG REMOVAL REAGENT (K924197)Zeus Scientific, Inc.1992-12-15
ACCUTEX CRP LATEX TEST (K924332)J.S. Medical Assoc.1992-12-07
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST (K915320)Trinity Laboratories, Inc.1992-12-07
VIGIL II (K920845)Beckman Instruments, Inc.1992-12-07
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST (K924036)J.S. Medical Assoc.1992-12-01
PULSE CRP TEST (K923768)Pulse Scientific, Inc.1992-12-01
ENCORE SM/RNP (K921870)Clark Laboratories, Inc.1992-12-01
VENTREX ALLERGEN DISC (K924044)Hycor Biomedical, Inc.1992-12-01
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL (K924843)General Biometrics, Inc.1992-12-01
ENCORE SM (K921572)Clark Laboratories, Inc.1992-12-01
SYN ELISA DSDNA ANTIBODIES (K921132)Elias U.S.A., Inc.1992-12-01
AUTOZYME (K922241)Cambridge Life Sciences Plc.1992-11-30
SYNELISA CARDIOLIPIN ANTIBODIES (K924421)Elias U.S.A., Inc.1992-11-30
VENTREX ALLERGEN DISC (K924119)Ventrex, Inc.1992-11-30
VENTREX ALLERGEN DISC (K924209)Hycor Biomedical, Inc.1992-11-30
PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION (K923832)Kabi Pharmacia, Inc.1992-11-25
MYOGLOBIN ELISA TEST KIT (K923195)Immuno Diagnostic Center, Inc.1992-11-06
ACCUTEX SLE LATEX TEST (K924248)J.S. Medical Assoc.1992-11-02
REP IMMUNOFIX (K923658)Helena Laboratories1992-11-02
KALESTAD ANA MICROPLATE EIA (K924087)Bio-Rad Laboratories, Inc.1992-11-02
ACCUTEX IM RBC TEST (K924037)J.S. Medical Assoc.1992-11-02
PULSE IM RED CELL TEST (K923767)Pulse Scientific, Inc.1992-10-16
ENCORE SS-B (K922340)Clark Laboratories, Inc.1992-10-16
ENCORE SS-A (K922157)Clark Laboratories, Inc.1992-10-13
LIQUICHEK RHEUMATOID FACTOR CONTROL (K923578)Bio-Rad1992-10-06
TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL (K922722)Simplicity Diagnostics, Inc.1992-10-05
PULSE RF TEST (K923771)Pulse Scientific, Inc.1992-10-05
TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL (K922725)Simplicity Diagnostics, Inc.1992-10-05
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL (K922726)Simplicity Diagnostics, Inc.1992-10-05
QUANTA LITE(TM) IGA ACA (K922351)Inova Diagnostics, Inc.1992-09-29
QUANTA LITE ACA SCREEN (K923320)Inova Diagnostics, Inc.1992-09-28
BASELINE CALIBRATION VERIFICATION CONTROLS (K923284)Hycor Biomedical, Inc.1992-09-28
ENCORE RHEUMATOID FACTOR EIA (K924056)Clark Laboratories, Inc.1992-09-25
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT (K923886)Shield Diagnostics, Ltd.1992-09-25
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY (K923421)Coulter Corp.1992-09-23
AUTOSTAT ANTI-THYROID MICROSSOMAL (K923371)Cogent Diagnotics , Ltd.1992-09-22
AUTOSTAT ANTI-THYROGLOBULIN (K923370)Cogent Diagnotics , Ltd.1992-09-22
QUANTA LITE RNP ELISA (K922833)Inova Diagnostics, Inc.1992-09-18
QUANTA LITE SS-B ELISA (K922832)Inova Diagnostics, Inc.1992-09-18
QUANTA LITE ENA ELISA (K922829)Inova Diagnostics, Inc.1992-09-18
QUANTA LITE SS-A ELISA (K922830)Inova Diagnostics, Inc.1992-09-18
QUANTA LITE SM ELISA (K922831)Inova Diagnostics, Inc.1992-09-18
IGE EIA TEST KIT (K920087)The Binding Site, Ltd.1992-09-14
866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS (K914685)In Vitro Technologies, Inc.1992-09-14
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM (K914959)Ciba Corning Diagnostics Corp.1992-08-20
AL-ACID GLYCOPROTEIN RID KIT (K922417)The Binding Site, Ltd.1992-08-20
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST (K920401)General Biometrics, Inc.1992-08-20
WAKO IGG-HA (K923070)Wako Chemicals USA, Inc.1992-08-20
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST (K920400)General Biometrics, Inc.1992-08-20
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 (K922047)Medix Biotech, Inc.1992-08-05
DIASTAT ANTI-CARDIOLIPIN KIT (K921265)Shield Diagnostics, Ltd.1992-08-03
WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC (K921574)Hycor Biomedical, Inc.1992-08-03
IL TEST ALPHA-1-ANTITRYPSIN (AAT) (K920005)Instrumentation Laboratory CO1992-07-29
IL TEST(TM) HAPTOGLOBIN (HPT) (K915829)Instrumentation Laboratory CO1992-07-29
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