Cleared Traditional

ENZYGNOST ANTI-VZV IGG TEST

K863317 · Behring Diagnostics, Inc. · Microbiology
Apr 1987
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K863317 is an FDA 510(k) clearance for the ENZYGNOST ANTI-VZV IGG TEST, a Antiserum, Cf, Varicella-zoster (Class II — Special Controls, product code GQX), submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on April 22, 1987, 239 days after receiving the submission on August 26, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K863317 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1986
Decision Date April 22, 1987
Days to Decision 239 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQX — Antiserum, Cf, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

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