Microgenics Corp. - FDA 510(k) Cleared Devices
107
Total
106
Cleared
1
Denied
107 devices
Cleared
Mar 03, 1994
CEDIA T4 MAB ASSAY MODIFICATION
Chemistry
87d
Cleared
Jan 25, 1994
CEDIA DAU 5-DRUG CALIBRATORS
Toxicology
49d
Cleared
Jan 25, 1994
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
Toxicology
49d
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
Jun 16, 1992
CEDIA RED BLOOD CELL FOLATE REAGENT PACK
Chemistry
69d
Cleared
Jun 04, 1992
CEDIA FERRITIN ASSAY
Chemistry
132d
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 20, 1990
CEDIA (R) VITAMIN B12/FOLATE ASSAY
Chemistry
29d
Cleared
Nov 05, 1990
CEDIA(TM) PHENOBARBITAL ASSAY
Toxicology
40d
Cleared
Sep 27, 1990
CEDIA TOTAL T3 ASSAY
Chemistry
21d
Cleared
Apr 03, 1990
CEDIA (TM) CORTISOL ASSAY
Chemistry
14d
Cleared
Dec 12, 1989
MODIFIED CEDIA(TM) CORTISOL ASSAY
Chemistry
33d
Cleared
Nov 08, 1989
CEDIA DIGITOXIN ASSAY
Toxicology
23d
Cleared
Oct 31, 1989
CEDIA CORTISOL ASSAY
Chemistry
152d
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