FDA 510(k) Application Details - DEN130032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130032
Device Name	XPERT MTB/RIF ASSAY
Applicant	CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	KERRY J FLOM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2013
Decision Date	07/25/2013
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review