FDA 510(k) Application Details - DEN240016

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240016
Device Name	Xpert HCV; GeneXpert Xpress System
Applicant	Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Suzette Chance Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2024
Decision Date	06/27/2024
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