Immuno Concepts, Inc. - FDA 510(k) Cleared Devices
36
Total
36
Cleared
0
Denied
FDA 510(k) Regulatory Record - Immuno Concepts, Inc. Immunology ✕
23 devices
Cleared
Nov 29, 2001
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
Immunology
45d
Cleared
Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
Immunology
43d
Cleared
Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
Immunology
43d
Cleared
Jul 23, 1999
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
Immunology
36d
Cleared
Dec 18, 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
Immunology
44d
Cleared
Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
Immunology
263d
Cleared
Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
Immunology
75d
Cleared
Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
Immunology
75d
Cleared
Sep 13, 1996
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
Immunology
24d
Cleared
Apr 19, 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
Immunology
133d
Cleared
Apr 19, 1996
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
Immunology
133d
Cleared
Apr 19, 1996
RELISA SM/RNP ANTIBODY TEST SYSTEM
Immunology
133d
Cleared
Apr 19, 1996
RELISA JO-1 ANTIBODY TEST SYSTEM
Immunology
133d
Cleared
Jun 01, 1995
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
Immunology
90d
Cleared
Jan 31, 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
Immunology
95d
Cleared
Jul 06, 1993
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
Immunology
60d
Cleared
Dec 09, 1991
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
Immunology
241d
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