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FDA 510(k) Applications Submitted by KAREN LEE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K120936
03/28/2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
Microgenics Corporation
K122291
07/31/2012
THERMO SCIENTIFIC MAS OMNI-CARDIO
Microgenics Corporation
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.
K123518
11/14/2012
ABBOTT CARBAMAZEPINE ASSAY
Microgenics Corporation
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