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Immunology

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

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RecordFirmDate
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY (K952055)American Laboratory Products Co., Ltd.1995-07-18
N/T PROTEIN CONTROL SY/L, M AND H (K952593)Behring Diagnostics, Inc.1995-07-17
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (K951798)Helix Diagnostics, Inc.1995-07-17
N PROTEIN STANDARD SY (K952594)Behring Diagnostics, Inc.1995-07-17
UBI MAGIWEL FERRITIN QUANTITATIVE (K951993)United Biotech, Inc.1995-07-05
DIASTAT ANTI-THYROID PEROXIDASE KIT (K951487)Shield Diagnostics, Ltd.1995-06-30
SPECIFIC IGE ULTRA-EIA (K945884)Hycor Biomedical, Inc.1995-06-30
DIASTAT ANTI-THYROGLOBULIN KIT (K952183)Shield Diagnostics, Ltd.1995-06-30
ORGENTEC ANTI-TG ELISA (K952130)American Laboratory Products Co., Ltd.1995-06-20
AMERLITE FERRITIN II ASSAY (K952286)Johnson & Johnson Clinical Diagnostics, Inc.1995-06-20
ORGENTEC ANTI-TPO ELISA (K952129)American Laboratory Products Co., Ltd.1995-06-20
AURAFLEX B2-MICROGLOBULIN (K944846)Organon Teknika Corp.1995-06-20
N LATEX IGA (K952309)Behring Diagnostics, Inc.1995-06-20
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY (K945748)Hycor Biomedical, Inc.1995-06-07
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K952077)Hemagen Diagnostics, Inc.1995-06-05
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K952076)Hemagen Diagnostics, Inc.1995-06-05
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (K951966)Kent Laboratories, Inc.1995-06-01
HEP-2000 COLORZYME ANA-RO TEST SYSTEM (K950979)Immuno Concepts, Inc.1995-06-01
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT (K951967)Kent Laboratories, Inc.1995-05-30
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (K951968)Kent Laboratories, Inc.1995-05-30
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR (K950629)Bio-Rad Laboratories, Inc.1995-05-23
ACE(TM) CEDIA(R) FERRITIN ASSAY (K950393)Schiapparelli Biosystems, Inc.1995-05-16
IL TEST BETA-2MICROGLOBULIN (K943686)Instrumentation Laboratory CO1995-05-15
MARDX ENA EIA TEST SYSTEM (K946218)Hogan & Hartson1995-05-15
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL (K951635)Beckman Instruments, Inc.1995-05-15
MARDX MITOCHONDRIA EIA TEST SYSTEM (K950110)Hogan & Hartson1995-05-15
LEUKO-TEST (K951101)Techlab, Inc.1995-04-24
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) (K950217)American Laboratory Products Co., Ltd.1995-04-24
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950090)American Laboratory Products Co., Ltd.1995-04-21
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) (K950089)American Laboratory Products Co., Ltd.1995-04-21
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) (K950088)American Laboratory Products Co., Ltd.1995-04-21
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 (K951057)Medical Analysis Systems, Inc.1995-04-20
DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY (K931192)Dako Corp.1995-04-20
VARELISA ANA PROFILE (K951205)Elias U.S.A., Inc.1995-04-17
VARELISA PARIETAL CELL ANTIBODIES (K951206)Elias U.S.A., Inc.1995-04-17
AUTOSTAT II ANTI-TPO (K943580)Cogent Diagnotics , Ltd.1995-04-17
VARELISA COMBINED DNA ANTIBODIES EIA (K944334)Elias U.S.A., Inc.1995-04-17
OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT (K951055)Olympus America, Inc.1995-04-17
VARELISA ANA-4 SCREEN (K951186)Elias U.S.A., Inc.1995-04-17
OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT (K951013)Olympus America, Inc.1995-04-17
VARELISA HISTONE ANTIBODIES (K951207)Elias U.S.A., Inc.1995-04-17
HUMAN C-5 RADIAL IMMUNODIFFUSION KIT (K950102)Kent Laboratories, Inc.1995-04-10
HEMAGEN ENA SM/RMP KIT (EIA METHOD) (K950414)Hemagen Diagnostics, Inc.1995-03-29
OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT (K950900)Olympus America, Inc.1995-03-27
N LATEX FERRITIN (K950707)Behring Diagnostics, Inc.1995-03-27
LATEX (K82) (K931746)Diagnostic Products Corp.1995-03-21
HY-TEC AUTOMATED EIA SYSTEM (K941278)Hycor Biomedical, Inc.1995-03-13
VARELISA DSDNA ANTIBODIES (FARR VERSION) (K950031)Elias U.S.A., Inc.1995-03-10
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (K945280)Dupont Medical Products1995-03-09
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST (K933786)Immco Diagnostics, Inc.1995-03-07
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST (K933788)Immco Diagnostics, Inc.1995-03-07
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) (K933784)Immco Diagnostics, Inc.1995-03-07
DIASTAT ANTI-PR3 (C-ANCA) KIT (K942813)Shield Diagnostics, Ltd.1995-03-06
DIASTAT ANTI-MPO (PANCA) KIT (K943630)Shield Diagnostics, Ltd.1995-03-06
ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER (K944191)Light Diagnostics1995-03-06
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT (K943768)Diagnostic Products Corp.1995-03-06
ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (K944192)Light Diagnostics1995-03-06
I.D. AND SEAKEM GTG AGAROSES (K940037)Fmc Corp.1995-02-24
IMMULITE(R) ALLERGY FOOD PANEL FP5E (K943194)Diagnostic Products Corp.1995-02-23
HEMAGEN ENA SS-A KIT (EIA METHOD) (K946121)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SS-B KIT (EIA METHOD) (K946120)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA JO-1 KIT (EIA METHOD) (K946124)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SM KIT (EIA METHOD) (K946123)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K946122)Hemagen Diagnostics, Inc.1995-02-22
FERRITIN CONTROL - LEVEL 1, 2, 3 (K946266)Clinical Controls, Inc.1995-02-10
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 (K946048)Clinical Controls, Inc.1995-02-10
LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 (K946050)Clinical Controls, Inc.1995-02-10
LIFESIGN MI MYOGLOBIN (K942052)Princeton Biomedix1995-02-07
VARELISA M2 ANTIBODIES (K945607)Elias U.S.A., Inc.1995-01-24
SPECIFIC IGE EIA-ULTRA ASSAY (K941057)Hycor Biomedical, Inc.1995-01-20
IGM RF EIA (K942908)Sigma Diagnostics, Inc.1995-01-20
ANTI-HISTONE ANIBODY TEST (K943585)Immco Diagnostics, Inc.1995-01-20
VARELISA CENTROMERE ANTIBODIES (K944171)Elias U.S.A., Inc.1994-12-22
VARELISA SM ANTIBODIES (K944170)Elias U.S.A., Inc.1994-12-22
VARELISA JO-1 ANTIBODIES (K944173)Elias U.S.A., Inc.1994-12-22
VARELISA RO (SS-A) ANTIBODIES (K944169)Elias U.S.A., Inc.1994-12-22
AUTOSTAT II ANTI-THYROGLOBULIN (K943625)Cogent Diagnotics , Ltd.1994-12-22
VARELISA SCL-70 ANTIBODIES (K944172)Elias U.S.A., Inc.1994-12-22
VARELISA LA (SS-B) ANTIBODIES (K944168)Elias U.S.A., Inc.1994-12-22
VARELISA RNP-SM ANTIBODIES (K944167)Elias U.S.A., Inc.1994-12-22
IMMULITE ALATOP ALLERGY SCREEN (K941564)Diagnostic Products Corp.1994-12-19
HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (K944876)Research Diagnostics, Inc.1994-12-15
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS (K945522)Beckman-Diagnostic Systems Group1994-12-12
ANTI DS-DNA (K943291)Sigma Diagnostics, Inc.1994-12-02
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (K944096)Immuno Concepts, Inc.1994-11-21
DIASTAT ENA SINGLE WELL SCREEN KIT (K944505)Shield Diagnostics, Ltd.1994-11-21
DAKO MOUSE ANTI-HUMAN T-CELL (K924804)Dako Corp.1994-11-21
QUANTA LITE ENA 5 ELISA KIT (K943076)Inova Diagnostics, Inc.1994-10-25
N LATEX RF (K942328)Behring Diagnostics, Inc.1994-10-20
APHLELISA KIT (K933588)Louisville Apl Diagnostics, Inc.1994-10-13
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) (K944288)Hemagen Diagnostics, Inc.1994-10-03
BEHRING NEPHELOMETER II (K943997)Behring Diagnostics, Inc.1994-10-03
N/T RHEUMATOLOGY CONTROL SL/1, SL/2 (K944375)Behring Diagnostics, Inc.1994-10-03
IGM RHEUMATOID FACTOR (K942272)Immco Diagnostics, Inc.1994-09-26
ANTI-RETICULIN ANTIBODY (ARA) TEST (K913360)Immco Diagnostics, Inc.1994-09-26
ELIAS CARDIOLIPIN ANTIBODIES (K940403)Elias U.S.A., Inc.1994-09-20
PLASMINOGEN RID TEST KIT (K941346)The Binding Site, Ltd.1994-09-09
HUMAN IGG SUBCLASSES ELISA COMBI KIT (K943098)Research Diagnostics, Inc.1994-09-07
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (K943205)Research Diagnostics, Inc.1994-09-07
VENTANA EMA PRIMARY ANDIBODY (K940243)Ventana Medical Systems, Inc.1994-09-07
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