Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

107 results for "Microgenics Corp."
25–48 of 107
Search insights Median review: 67d Cleared: 99% Top manufacturer: Microgenics Corp. Lead specialty: Toxicology
Cleared Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
K032811 · LEH
Microgenics Corp.
Toxicology · 76d
Cleared Oct 17, 2003
MICROGENICS CYCLOSPORINE CONTROL KIT
K032842 · LAS
Microgenics Corp.
Chemistry · 36d
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · DJR
Microgenics Corp.
Toxicology · 302d
Cleared May 22, 2003
DRI COTININE EIA ASSAY
K030649 · MRS
Microgenics Corp.
Toxicology · 83d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · LAS
Microgenics Corp.
Toxicology · 33d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · DLJ
Microgenics Corp.
Toxicology · 90d
Cleared Oct 24, 2002
CEDIA CYCLOSPORINE PLUS ASSAY
K023208 · MKW
Microgenics Corp.
Chemistry · 29d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · DKZ
Microgenics Corp.
Toxicology · 52d
Cleared Aug 27, 2001
DRI ECSTASY URINE CALIBRATORS
K012109 · DLJ
Microgenics Corp.
Toxicology · 52d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150 · DJG
Microgenics Corp.
Toxicology · 65d
Cleared May 29, 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · LAF
Microgenics Corp.
Toxicology · 97d
Cleared Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · DJG
Microgenics Corp.
Toxicology · 59d
Cleared May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
K994380 · DKZ
Microgenics Corp.
Toxicology · 127d
Cleared Feb 09, 1996
CEDIA DAU LSD ASSAY
K955814 · DLB
Microgenics Corp.
Toxicology · 45d
Cleared Feb 09, 1996
CEDIA DAU LSD CALBIRATORS
K955813 · DLJ
Microgenics Corp.
Toxicology · 45d
Cleared Nov 27, 1995
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
K954626 · JXM
Microgenics Corp.
Toxicology · 55d
Cleared Nov 17, 1995
CEDIA DAU METHADONE ASSAY
K954227 · DJR
Microgenics Corp.
Toxicology · 67d
Cleared Jul 11, 1995
CEDIA VITAMIN B12 (NO BOIL) ASSAY
K951134 · CDD
Microgenics Corp.
Chemistry · 120d
Cleared Jun 29, 1995
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · CGN
Microgenics Corp.
Chemistry · 107d
Cleared Jun 20, 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710 · JXM
Microgenics Corp.
Toxicology · 67d
Cleared May 08, 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154 · DKZ
Microgenics Corp.
Toxicology · 55d
Cleared May 02, 1995
CEDIA DAU PROPOXYPHENE ASSAY
K951133 · JXN
Microgenics Corp.
Toxicology · 50d
Cleared Apr 21, 1995
CEDIA DAU PPX/METH CALIBRATOR
K951153 · DLJ
Microgenics Corp.
Toxicology · 38d
Cleared Apr 13, 1995
MULTI-DRUG CONTROL SET
K951135 · DIF
Microgenics Corp.
Chemistry · 31d