Immuno Concepts, Inc. - FDA 510(k) Cleared Devices
36
Total
36
Cleared
0
Denied
36 devices
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
Cleared
May 15, 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
Immunology
100d
Cleared
Mar 28, 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
Immunology
36d
Cleared
Nov 01, 1984
COLORZYME NDNA TEST SYSTEM
Immunology
77d
Cleared
Nov 21, 1983
ENZYME ANA TEST SYSTEM
Immunology
67d
Cleared
Feb 25, 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
Immunology
21d
Cleared
Jan 26, 1981
ANA-IFA TEST SYSTEM
Immunology
28d