Cleared Traditional

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG

K081687 · DiaSorin, Inc. · Microbiology

Nov 2008

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K081687 is an FDA 510(k) clearance for the LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG, a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II — Special Controls, product code MYF), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on November 10, 2008, 146 days after receiving the submission on June 17, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K081687 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2008
Decision Date	November 10, 2008
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3305