FDA 510(k) Application Details - K143236

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1   More FDA Info for this Device
510(K) Number	K143236
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant	THERANOS, INC. 1701 PAGE MILL ROAD PALO ALTO, CA 94304 US Other 510(k) Applications for this Company
Contact	Brad Arington 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	11/12/2014
Decision Date	07/02/2015
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