FDA 510(k) Application Details - K082118

Device Classification Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K082118
Device Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr
Applicant	CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089-1189 US Other 510(k) Applications for this Company
Contact	RUSSEL K ENNS 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	07/28/2008
Decision Date	09/18/2009
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