Medical Device Manufacturer · US , Concord , CA

Microgenics Corp. - FDA 510(k) Cleared Devices

107 submissions · 106 cleared · Since 1985
107
Total
106
Cleared
1
Denied
107 devices
26-50 of 107
Cleared Oct 17, 2003
MICROGENICS CYCLOSPORINE CONTROL KIT
K032842 · LAS
Chemistry · 36d
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · DJR
Toxicology · 302d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · MRS
Toxicology · 83d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · LAS
Toxicology · 33d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · DLJ
Toxicology · 90d
Cleared Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · MKW
Chemistry · 29d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · DLJ
Toxicology · 52d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · DKZ
Toxicology · 52d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · DJG
Toxicology · 65d
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · LAF
Toxicology · 97d
Cleared Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · DJG
Toxicology · 59d
Cleared May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · DKZ
Toxicology · 127d
Cleared Feb 09, 1996
CEDIA DAU LSD CALBIRATORS
K955813 · DLJ
Toxicology · 45d
Cleared Feb 09, 1996
CEDIA DAU LSD ASSAY
K955814 · DLB
Toxicology · 45d
Cleared Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
K954626 · JXM
Toxicology · 55d
Cleared Nov 17, 1995
CEDIA DAU METHADONE ASSAY
K954227 · DJR
Toxicology · 67d
Cleared Jul 11, 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · CDD
Chemistry · 120d
Cleared Jun 29, 1995
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · CGN
Chemistry · 107d
Cleared Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710 · JXM
Toxicology · 67d
Cleared May 08, 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · DKZ
Toxicology · 55d
Cleared May 02, 1995
CEDIA DAU PROPOXYPHENE ASSAY
K951133 · JXN
Toxicology · 50d
Cleared Apr 21, 1995
CEDIA DAU PPX/METH CALIBRATOR
K951153 · DLJ
Toxicology · 38d
Cleared Apr 13, 1995
MULTI-DRUG CONTROL SET
K951135 · DIF
Chemistry · 31d
Cleared Jan 17, 1995
CEDIA DAU OPIATE ASSAY
K945343 · DJG
Toxicology · 77d
Cleared Jan 17, 1995
CEDIA DAU COCAINE ASSAY
K945345 · DIO
Toxicology · 77d

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