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FDA 510(k) Application Details - K101752
Device Classification Name
Calibrators, Drug Mixture
More FDA Info for this Device
510(K) Number
K101752
Device Name
Calibrators, Drug Mixture
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD
FREMONT, CA 94538 US
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Contact
LISA CHARTER
Other 510(k) Applications for this Contact
Regulation Number
862.3200
More FDA Info for this Regulation Number
Classification Product Code
DKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2010
Decision Date
04/08/2011
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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