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Immuno Concepts, Inc.

36 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (K013432)Immuno Concepts, Inc.2001-11-29
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (K013285)Immuno Concepts, Inc.2001-11-14
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (K013283)Immuno Concepts, Inc.2001-11-14
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (K992041)Immuno Concepts, Inc.1999-07-23
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (K983924)Immuno Concepts, Inc.1998-12-18
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (K972145)Immuno Concepts, Inc.1998-02-24
IMMUNO CONCEPTS ANCA TEST SYSTEM (K974463)Immuno Concepts, Inc.1998-02-09
IMMUNO CONCEPTS ANCA TEST SYSTEMS (K974478)Immuno Concepts, Inc.1998-02-09
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (K963275)Immuno Concepts, Inc.1996-09-13
RELISA SM/RNP ANTIBODY TEST SYSTEM (K955604)Immuno Concepts, Inc.1996-04-19
RELSIA SCL-70 ANTIBODY TEST SYSTEM (K955602)Immuno Concepts, Inc.1996-04-19
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (K955603)Immuno Concepts, Inc.1996-04-19
RELISA JO-1 ANTIBODY TEST SYSTEM (K955605)Immuno Concepts, Inc.1996-04-19
HEP-2000 COLORZYME ANA-RO TEST SYSTEM (K950979)Immuno Concepts, Inc.1995-06-01
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (K944096)Immuno Concepts, Inc.1994-11-21
RELISA ENA ANTIBODY SCREENING TEST SYSTEM (K935129)Immuno Concepts, Inc.1994-01-31
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM (K932225)Immuno Concepts, Inc.1993-07-06
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM (K911661)Immuno Concepts, Inc.1991-12-09
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912489)Immuno Concepts, Inc.1991-07-24
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS (K912488)Immuno Concepts, Inc.1991-07-24
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) (K895708)Immuno Concepts, Inc.1989-12-11
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) (K895707)Immuno Concepts, Inc.1989-12-08
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893465)Immuno Concepts, Inc.1989-07-25
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (K893468)Immuno Concepts, Inc.1989-07-14
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) (K893467)Immuno Concepts, Inc.1989-07-14
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (K893466)Immuno Concepts, Inc.1989-07-14
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) (K880884)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (K880885)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (K880883)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) (K880886)Immuno Concepts, Inc.1988-08-30
SM-RNP AUTOANTIBODY TEST SYSTEM (K860428)Immuno Concepts, Inc.1986-05-15
SS-A/SS-B AUTOANTIBODY TEST SYSTEM (K860644)Immuno Concepts, Inc.1986-03-28
COLORZYME NDNA TEST SYSTEM (K843225)Immuno Concepts, Inc.1984-11-01
ENZYME ANA TEST SYSTEM (K833148)Immuno Concepts, Inc.1983-11-21
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST (K810301)Immuno Concepts, Inc.1981-02-25
ANA-IFA TEST SYSTEM (K803276)Immuno Concepts, Inc.1981-01-26

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Every clearance here is in the API, with alerts when new ones post.