Cleared Traditional

LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT

K081527 · Millipore Corporation · Microbiology

Apr 2009

Decision

303d

Days

Class 2

Risk

About This 510(k) Submission

K081527 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Millipore Corporation (Temecula, US). The FDA issued a Cleared decision on April 1, 2009, 303 days after receiving the submission on June 2, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number	K081527 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2008
Decision Date	April 01, 2009
Days to Decision	303 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF