FDA 510(k) Applications Submitted by MICROGENICS CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K001178 04/11/2000 CEDIA DAU 6-ACETYLMORPHINE ASSAY MICROGENICS CORP.
K040316 02/09/2004 CEDIA BUPRENORPHINE ASSAY MICROGENICS CORP.
K040411 02/18/2004 DRI OXYCODONE ASSAY MICROGENICS CORP.
K040758 03/25/2004 MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT MICROGENICS CORP.
K041073 04/26/2004 DOCUMENT SALICYLATE CAL VER MICROGENICS CORP.
DEN040008 06/17/2004 CEDIA SIROLIMUS ASSAY MICROGENICS CORP.
K032811 09/09/2003 CEDIA VANCOMYCIN ASSAY MICROGENICS CORP.
K032842 09/11/2003 MICROGENICS CYCLOSPORINE CONTROL KIT MICROGENICS CORP.
K093114 10/01/2009 THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY MICROGENICS CORP.
K122766 09/10/2012 THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY MICROGENICS CORP.
K123271 10/19/2012 ABBOTT PHENOBARBITAL ASSAY MICROGENICS CORP.
K123343 10/31/2012 THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS MICROGENICS CORP.
K030649 02/28/2003 DRI COTININE EIA ASSAY MICROGENICS CORP.
K023617 10/29/2002 DRI METHADONE METABOLITE ENZYME IMMUNOASSAY MICROGENICS CORP.
K023780 11/12/2002 DRI PRIMIDONE CALIBRATORS MICROGENICS CORP.
K100144 01/19/2010 THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS MICROGENICS CORP.
K050206 01/28/2005 CEDIA TACROLIMUS ASSAY MICROGENICS CORP.
K110616 03/03/2011 THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO MICROGENICS CORP.
K090810 03/25/2009 THERMO SCIENTIFIC CYTO-CAL COUNT TUBES MICROGENICS CORP.
K051074 04/27/2005 MAS IMMUNOSUPPRESSANT CONTROLS MICROGENICS CORP.
K101742 06/22/2010 THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY MICROGENICS CORP.
K101744 06/22/2010 THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY MICROGENICS CORP.
K101745 06/22/2010 THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY MICROGENICS CORP.
K101746 06/22/2010 THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY MICROGENICS CORP.
K101752 06/22/2010 THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS MICROGENICS CORP.
K101753 06/22/2010 THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY MICROGENICS CORP.
K101754 06/22/2010 THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY MICROGENICS CORP.
K092051 07/07/2009 THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 MICROGENICS CORP.
K023208 09/25/2002 CEDIA CYCLOSPORINE PLUS ASSAY MICROGENICS CORP.
K955813 12/26/1995 CEDIA DAU LSD CALBIRATORS MICROGENICS CORP.
K955814 12/26/1995 CEDIA DAU LSD ASSAY MICROGENICS CORP.
K994380 12/27/1999 CEDIA DAU AMPHASSURE ASSAY MICROGENICS CORP.
K030616 02/26/2003 CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 MICROGENICS CORP.
K061196 04/28/2006 CARDIOIMMUNE XL CARDIAC MARKER CONTROL MICROGENICS CORP.
K010496 02/21/2001 CEDIA DAU AMPHETAMINES/ECSTASY ASSAY MICROGENICS CORP.
K011150 04/16/2001 DRIDAU OPIATE ASSAY MICROGENICS CORP.
K012110 07/06/2001 DRI ECSTASY ENZYME IMMUNOASSAY MICROGENICS CORP.
K012109 07/06/2001 DRI ECSTASY URINE CALIBRATORS MICROGENICS CORP.
K053411 12/07/2005 DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS MICROGENICS CORP.


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