FDA 510(k) Application Details - K212213

Device Classification Name	More FDA Info for this Device
510(K) Number	K212213
Device Name	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Applicant	Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Suzette Chance Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2021
Decision Date	02/09/2022
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