Cleared Traditional

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

K120625 · Roche Diagnostics · Microbiology

Jul 2012

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K120625 is an FDA 510(k) clearance for the ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II — Special Controls, product code MXJ), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 25, 2012, 146 days after receiving the submission on March 1, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K120625 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2012
Decision Date	July 25, 2012
Days to Decision	146 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