Microgenics Corp. - FDA 510(k) Cleared Devices
107
Total
106
Cleared
1
Denied
66 devices
Cleared
Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
Toxicology
55d
Cleared
Jan 11, 1994
CEDIA(R) DAU OPIATE ASSAY
Toxicology
67d
Cleared
Dec 29, 1993
CEDIA DIGOXIN PLUS ASSAY
Toxicology
124d
Cleared
Sep 21, 1993
CEDIA VALPORIC ACID ASSAY
Toxicology
222d
Cleared
Sep 15, 1992
CEDIA DIGOXIN PLUS ASSAY
Toxicology
50d
Cleared
Mar 02, 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
Toxicology
46d
Cleared
Jan 15, 1992
CEDIA(R) CARBAMAZEPINE ASSAY
Toxicology
78d
Cleared
Sep 27, 1991
CEDIA(R) GENTAMICIN ASSAY
Toxicology
53d
Cleared
Jul 26, 1991
CEDIA(R) TOBRAMYCIN ASSAY
Toxicology
72d
Cleared
May 15, 1991
CEDIA(R) DIGOXIN R' ASSAY
Toxicology
14d
Cleared
Mar 21, 1991
CEDIA(R) DIGOXIN SC ASSAY
Toxicology
36d
Cleared
Jan 17, 1991
CEDIA PHENYTOIN ASSAY
Toxicology
29d
Cleared
Dec 26, 1990
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
Toxicology
19d
Cleared
Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
Toxicology
40d
Cleared
Nov 08, 1989
CEDIA DIGITOXIN ASSAY
Toxicology
23d
Cleared
Feb 07, 1989
CEDIA THEOPHYLLINE ASSAY
Toxicology
113d