FDA 510(k) Application Details - K181205

Device Classification Name	More FDA Info for this Device
510(K) Number	K181205
Device Name	Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Applicant	Centers for Disease Control and Prevention 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	PBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2018
Decision Date	09/20/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review