FDA 510(k) Application Details - DEN070001

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN070001
Device Name	NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	HYE-JOO KIM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2007
Decision Date	09/21/2018
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