FDA 510(k) Application Details - K191168

Device Classification Name	More FDA Info for this Device
510(K) Number	K191168
Device Name	Cepheid Xpert SA Nasal Complete Control Panel
Applicant	Microbiologics, Inc. 200 Cooper Avenue North St. Cloud, MN 56303 US Other 510(k) Applications for this Company
Contact	Tina Sobania Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2019
Decision Date	06/25/2019
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