FDA 510(k) Application Details - DEN030005

Device Classification Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	DEN030005
Device Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	ROBERT A GREGG Other 510(k) Applications for this Contact
Regulation Number	864.7280   More FDA Info for this Regulation Number
Classification Product Code	NPQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2003
Decision Date	12/17/2003
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review