Cleared Traditional

HERPES VIRUS CONTROL SLIDES

K883684 · Val Tech Diagnostics, Inc. · Microbiology
Sep 1988
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K883684 is an FDA 510(k) clearance for the HERPES VIRUS CONTROL SLIDES, a Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQN), submitted by Val Tech Diagnostics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on September 28, 1988, 30 days after receiving the submission on August 29, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K883684 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1988
Decision Date September 28, 1988
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

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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