Cleared Traditional

Theranos Herpes Simplex Virus-1 IgG Assay

K143236 · Theranos, Inc. · Microbiology

Jul 2015

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K143236 is an FDA 510(k) clearance for the Theranos Herpes Simplex Virus-1 IgG Assay, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Theranos, Inc. (Palo Alto, US). The FDA issued a Cleared decision on July 2, 2015, 232 days after receiving the submission on November 12, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K143236 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2014
Decision Date	July 02, 2015
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305