FDA 510(k) Application Details - K150962

Device Classification Name	More FDA Info for this Device
510(K) Number	K150962
Device Name	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Applicant	FOCUS DIAGNOSTICS 11331 VALLEY VIEW STREET CYPRESS, CA 90630 US Other 510(k) Applications for this Company
Contact	SHARON YOUNG Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2015
Decision Date	08/28/2015
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