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FDA 510(k) Application Details - K122766
Device Classification Name
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510(K) Number
K122766
Device Name
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT, CA 94538 US
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Contact
KAREN LEE
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Regulation Number
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Classification Product Code
OUF
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Date Received
09/10/2012
Decision Date
08/20/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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