FDA 510(k) Application Details - K250995

Device Classification Name	More FDA Info for this Device
510(K) Number	K250995
Device Name	Xpert Xpress CoV-2/Flu/RSV plus
Applicant	Cepheid« 904 Caribbean Dive 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	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2025
Decision Date	05/01/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review