FDA 510(k) Application Details - DEN040011

Device Classification Name	Drug Metabolizing Enzyme Genotyping Systems   More FDA Info for this Device
510(K) Number	DEN040011
Device Name	Drug Metabolizing Enzyme Genotyping Systems
Applicant	ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	JAMES F KELLY Other 510(k) Applications for this Contact
Regulation Number	862.3360   More FDA Info for this Regulation Number
Classification Product Code	NTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2004
Decision Date	12/23/2004
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