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Immuno Concepts, Inc.

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K013432 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GKTL2001-11-29 View
510(k) K013285 RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15MOB2001-11-14 View
510(k) K013283 RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16MOB2001-11-14 View
510(k) K992041 RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11LJM1999-07-23 View
510(k) K983924 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RODHN1998-12-18 View
510(k) K972145 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMDHN1998-02-24 View
510(k) K974463 IMMUNO CONCEPTS ANCA TEST SYSTEMMOB1998-02-09 View
510(k) K974478 IMMUNO CONCEPTS ANCA TEST SYSTEMSMOB1998-02-09 View
510(k) K963275 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEMLLL1996-09-13 View
510(k) K955605 RELISA JO-1 ANTIBODY TEST SYSTEMLLL1996-04-19 View
510(k) K955603 RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEMLLL1996-04-19 View
510(k) K955602 RELSIA SCL-70 ANTIBODY TEST SYSTEMLLL1996-04-19 View
510(k) K955604 RELISA SM/RNP ANTIBODY TEST SYSTEMLLL1996-04-19 View
510(k) K950979 HEP-2000 COLORZYME ANA-RO TEST SYSTEMDHN1995-06-01 View
510(k) K944096 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEMDHN1994-11-21 View
510(k) K935129 RELISA ENA ANTIBODY SCREENING TEST SYSTEMLLL1994-01-31 View
510(k) K932225 ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEMMID1993-07-06 View
510(k) K911661 ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEMMID1991-12-09 View
510(k) K912489 COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYSLSE1991-07-24 View
510(k) K912488 FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYSLSE1991-07-24 View
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