Cleared Traditional

HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST

K131334 · Gold Standard Diagnostics · Microbiology

Feb 2014

Decision

295d

Days

Class 2

Risk

About This 510(k) Submission

K131334 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on February 28, 2014, 295 days after receiving the submission on May 9, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K131334 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2013
Decision Date	February 28, 2014
Days to Decision	295 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