Immuno Concepts, Inc. - FDA 510(k) Cleared Devices
Recent clearances: IGG ANTI-NDNA FLUORESCENT TEST SYSTEM, RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16, RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
36
Total
36
Cleared
0
Denied
FDA 510(k) Regulatory Record - Immuno Concepts, Inc. Microbiology ✕
13 devices
Cleared
Nov 21, 1994
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
Microbiology
91d
Cleared
Jul 24, 1991
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
Microbiology
50d
Cleared
Jul 24, 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
Microbiology
50d
Cleared
Dec 11, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
Microbiology
77d
Cleared
Dec 08, 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
Microbiology
74d
Cleared
Jul 25, 1989
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
Microbiology
83d
Cleared
Jul 14, 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
Microbiology
72d
Cleared
Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)
Microbiology
72d
Cleared
Jul 14, 1989
CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
Microbiology
72d
Cleared
Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
Microbiology
181d
Cleared
Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
Microbiology
181d
Cleared
Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
Microbiology
181d
Cleared
Aug 30, 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
Microbiology
181d