FDA 510(k) Application Details - K170940

Device Classification Name	More FDA Info for this Device
510(K) Number	K170940
Device Name	Rickettsia Real-time PCR Assay
Applicant	Centers for Disease Control and Prevention (CDC) 1600 Clifton Road 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	PVQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2017
Decision Date	06/29/2017
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