FDA 510(k) Application Details - K152353

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2   More FDA Info for this Device
510(K) Number	K152353
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant	Quest International, Inc. 8127 NW 29th Street Miami, FL 33122 US Other 510(k) Applications for this Company
Contact	David J Kiefer Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2015
Decision Date	05/13/2016
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