FDA 510(k) Application Details - K151565

Device Classification Name	More FDA Info for this Device
510(K) Number	K151565
Device Name	Xpert« TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
Applicant	CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	KERRY J. FLOM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2015
Decision Date	10/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review