FDA 510(k) Application Details - K141458

Device Classification Name	More FDA Info for this Device
510(K) Number	K141458
Device Name	SIMPLEXA HSV 1&2 DIRECT/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	PGH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2014
Decision Date	07/01/2014
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