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FDA 510(k) Application Details - DEN040008
Device Classification Name
Sirolimus Test System
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510(K) Number
DEN040008
Device Name
Sirolimus Test System
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT, CA 94538 US
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DAVID CASAL
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Regulation Number
862.3840
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Classification Product Code
NRP
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Date Received
06/17/2004
Decision Date
07/28/2004
Decision
DENG -
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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