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Microgenics Corp

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
107
Inspections
0
Compliance Actions
0

Known Names

microgenics corporation, microgenics

Recent Recalls

NumberClassProductDate
Z-0513-2014Class IIThermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, ProductOctober 16, 2013
Z-2267-2013Class IIDRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IJuly 23, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYAugust 20, 2013
K123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSJuly 11, 2013
K123271ABBOTT PHENOBARBITAL ASSAYApril 26, 2013
K110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROJune 29, 2011
K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSApril 8, 2011
K101744THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAYApril 8, 2011
K101745THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAYApril 8, 2011
K101753THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAYApril 8, 2011
K101742THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAYApril 8, 2011
K101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAYApril 8, 2011
K101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYApril 8, 2011
K100144THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLSFebruary 11, 2011
K093114THERMO SCIENTIFIC DRI AMPHETAMINES ASSAYMay 12, 2010
K092051THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5September 21, 2009
K090810THERMO SCIENTIFIC CYTO-CAL COUNT TUBESSeptember 18, 2009
K061196CARDIOIMMUNE XL CARDIAC MARKER CONTROLMay 30, 2006
K053411DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORSFebruary 3, 2006
K051074MAS IMMUNOSUPPRESSANT CONTROLSJune 6, 2005
K050206CEDIA TACROLIMUS ASSAYMarch 15, 2005
DEN040008CEDIA SIROLIMUS ASSAYJuly 28, 2004