FDA 510(k) Application Details - DEN160016

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160016
Device Name	Variola virus Real-Time PCR Assay
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD NE, MS-C18 ATLANTA, GA 30329 US Other 510(k) Applications for this Company
Contact	YON YU Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2016
Decision Date	02/06/2017
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