Cleared Traditional

DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000

K070265 · Diagnostic Hybrids, Inc. · Microbiology
Oct 2007
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K070265 is an FDA 510(k) clearance for the DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000, 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 October 24, 2007, 268 days after receiving the submission on January 29, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K070265 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2007
Decision Date October 24, 2007
Days to Decision 268 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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