FDA 510(k) Application Details - DEN070004

Device Classification Name	Assay, Enterovirus Nucleic Acid   More FDA Info for this Device
510(K) Number	DEN070004
Device Name	Assay, Enterovirus Nucleic Acid
Applicant	CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089-1189 US Other 510(k) Applications for this Company
Contact	RUSSEL K ENNS, PH.D. Other 510(k) Applications for this Contact
Regulation Number	866.3225   More FDA Info for this Regulation Number
Classification Product Code	OAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2007
Decision Date	03/16/2007
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review