FDA 510(k) Application Details - K190076

Device Classification Name	More FDA Info for this Device
510(K) Number	K190076
Device Name	Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
Applicant	Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Yi-Ping Lin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2019
Decision Date	09/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MG -
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review