Cleared Traditional

DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000

K063798 · Diagnostic Hybrids, Inc. · Microbiology
Sep 2007
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K063798 is an FDA 510(k) clearance for the DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000, a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN), submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 21, 2007, 273 days after receiving the submission on December 22, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K063798 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2006
Decision Date September 21, 2007
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GQN — Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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