FDA 510(k) Application Details - K033612

Device Classification Name	Test, Factor Ii G20210a Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K033612
Device Name	Test, Factor Ii G20210a 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	NPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2003
Decision Date	12/18/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review