Cleared Traditional

HSV-1 ANTIGEN CONTROL SLIDES

K964874 · Viral Antigens, Inc. · Microbiology
Jul 1997
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K964874 is an FDA 510(k) clearance for the HSV-1 ANTIGEN CONTROL SLIDES, a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN), submitted by Viral Antigens, Inc. (Memphis, US). The FDA issued a Cleared decision on July 1, 1997, 208 days after receiving the submission on December 5, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K964874 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1996
Decision Date July 01, 1997
Days to Decision 208 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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