FDA 510(k) Application Details - DEN040008

Device Classification Name	Sirolimus Test System   More FDA Info for this Device
510(K) Number	DEN040008
Device Name	Sirolimus Test System
Applicant	MICROGENICS CORP. 46360 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	DAVID CASAL Other 510(k) Applications for this Contact
Regulation Number	862.3840   More FDA Info for this Regulation Number
Classification Product Code	NRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
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