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FDA 510(k) Application Details - K103656
Device Classification Name
Drug Mixture Control Materials
More FDA Info for this Device
510(K) Number
K103656
Device Name
Drug Mixture Control Materials
Applicant
Microgenics Corporation
46360 FREMONT BLVD.
FREMONT, CA 94538 US
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Contact
LISA CHARTER
Other 510(k) Applications for this Contact
Regulation Number
862.3280
More FDA Info for this Regulation Number
Classification Product Code
DIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2010
Decision Date
03/24/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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