Microgenics Corp. - FDA 510(k) Cleared Devices
107
Total
106
Cleared
1
Denied
107 devices
Cleared
Oct 17, 2003
MICROGENICS CYCLOSPORINE CONTROL KIT
Chemistry
36d
Cleared
Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
Toxicology
302d
Cleared
May 22, 2003
DRI COTININE EIA ASSAY
Toxicology
83d
Cleared
Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
Toxicology
33d
Cleared
Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
Toxicology
90d
Cleared
Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
Chemistry
29d
Cleared
Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
Toxicology
52d
Cleared
Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
Toxicology
52d
Cleared
Jun 20, 2001
DRIDAU OPIATE ASSAY
Toxicology
65d
Cleared
May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
Toxicology
97d
Cleared
Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
Toxicology
59d
Cleared
May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
Toxicology
127d
Cleared
Feb 09, 1996
CEDIA DAU LSD CALBIRATORS
Toxicology
45d
Cleared
Feb 09, 1996
CEDIA DAU LSD ASSAY
Toxicology
45d
Cleared
Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
Toxicology
55d
Cleared
Nov 17, 1995
CEDIA DAU METHADONE ASSAY
Toxicology
67d
Cleared
Jul 11, 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
Chemistry
120d
Cleared
Jun 29, 1995
CEDIA FOLATE (NO BOIL) ASSAY
Chemistry
107d
Cleared
Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
Toxicology
67d
Cleared
May 08, 1995
CEDIA DAU AMPHETAMINES ASSAY
Toxicology
55d
Cleared
May 02, 1995
CEDIA DAU PROPOXYPHENE ASSAY
Toxicology
50d
Cleared
Apr 21, 1995
CEDIA DAU PPX/METH CALIBRATOR
Toxicology
38d
Cleared
Apr 13, 1995
MULTI-DRUG CONTROL SET
Chemistry
31d
Cleared
Jan 17, 1995
CEDIA DAU OPIATE ASSAY
Toxicology
77d
Cleared
Jan 17, 1995
CEDIA DAU COCAINE ASSAY
Toxicology
77d
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