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."
1–24 of 107
Search insights Median review: 67d Cleared: 99% Top manufacturer: Microgenics Corp. Lead specialty: Toxicology
Cleared Aug 20, 2013
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
K122766 · OUF
Microgenics Corp.
Chemistry · 344d
Cleared Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · MLM
Microgenics Corp.
Toxicology · 253d
Cleared Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
K123271 · DLZ
Microgenics Corp.
Chemistry · 189d
Cleared Jun 29, 2011
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
K110616 · JJY
Microgenics Corp.
Chemistry · 118d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754 · DJG
Microgenics Corp.
Toxicology · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
K101753 · LAF
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
K101752 · DKB
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
K101746 · LCM
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · DKZ
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · LDJ
Microgenics Corp.
Chemistry · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742 · DIO
Microgenics Corp.
Toxicology · 290d
Cleared Feb 11, 2011
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
K100144 · OUF
Microgenics Corp.
Chemistry · 388d
Cleared May 12, 2010
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · DKZ
Microgenics Corp.
Chemistry · 223d
Cleared Sep 21, 2009
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY...
K092051 · JJY
Microgenics Corp.
Chemistry · 76d
Cleared Sep 18, 2009
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K090810 · GKZ
Microgenics Corp.
Hematology · 177d
Cleared May 30, 2006
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
K061196 · JJY
Microgenics Corp.
Chemistry · 32d
Cleared Feb 03, 2006
DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS
K053411 · LCP
Microgenics Corp.
Chemistry · 58d
Cleared Jun 06, 2005
MAS IMMUNOSUPPRESSANT CONTROLS
K051074 · LAS
Microgenics Corp.
Toxicology · 40d
Cleared Mar 15, 2005
CEDIA TACROLIMUS ASSAY
K050206 · MLM
Microgenics Corp.
Toxicology · 46d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008 · NRP
Microgenics Corp.
Chemistry · 41d
Cleared Jun 23, 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · DJG
Microgenics Corp.
Toxicology · 135d
Cleared May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · DIF
Microgenics Corp.
Toxicology · 64d
Cleared May 27, 2004
DRI OXYCODONE ASSAY
K040411 · LAS
Microgenics Corp.
Toxicology · 99d
Cleared May 21, 2004
DOCUMENT SALICYLATE CAL VER
K041073 · JJY
Microgenics Corp.
Chemistry · 25d