FDA 510(k) Application Details - K032842

Device Classification Name	Drug Specific Control Materials   More FDA Info for this Device
510(K) Number	K032842
Device Name	Drug Specific Control Materials
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	862.3280   More FDA Info for this Regulation Number
Classification Product Code	LAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2003
Decision Date	10/17/2003
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