FDA 510(k) Application Details - K131334

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1   More FDA Info for this Device
510(K) Number	K131334
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant	GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD ST DAVIS, CA 95618 US Other 510(k) Applications for this Company
Contact	NAPLEON MONCE Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MXJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2013
Decision Date	02/28/2014
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