Scimedx Corp. - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scimedx Corp. Immunology ✕
14 devices
Cleared
Jun 25, 2001
PHASE II GBM IGG ANTIBODY EIA TEST
Immunology
54d
Cleared
Jun 06, 2001
TPO IGG ANTIBODY EIA TEST
Immunology
57d
Cleared
Apr 24, 2001
EUROSPITAL EU-TTG IGA UMANA
Immunology
53d
Cleared
Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
Immunology
44d
Cleared
Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
Immunology
35d
Cleared
Oct 19, 2000
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
Immunology
93d
Cleared
Oct 19, 2000
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
Immunology
92d
Cleared
Aug 04, 2000
IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL...
Immunology
23d
Cleared
Feb 18, 2000
EU-TTG IGA ELISA
Immunology
53d
Cleared
Feb 20, 1997
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
Immunology
30d
Cleared
Sep 30, 1996
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
Immunology
103d
Cleared
Apr 10, 1996
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
Immunology
259d
Cleared
Mar 19, 1996
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
Immunology
203d
Cleared
Mar 19, 1996
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
Immunology
201d