Microgenics Corp. - FDA 510(k) Cleared Devices
107
Total
106
Cleared
1
Denied
66 devices
Cleared
Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
Toxicology
253d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
Toxicology
290d
Cleared
Apr 08, 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
Toxicology
290d
Cleared
Jun 06, 2005
MAS IMMUNOSUPPRESSANT CONTROLS
Toxicology
40d
Cleared
Mar 15, 2005
CEDIA TACROLIMUS ASSAY
Toxicology
46d
Cleared
Jun 23, 2004
CEDIA BUPRENORPHINE ASSAY
Toxicology
135d
Cleared
May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
Toxicology
64d
Cleared
May 27, 2004
DRI OXYCODONE ASSAY
Toxicology
99d
Cleared
Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
Toxicology
76d
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
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