Cleared Traditional

VARICELLA ZOSTER VIRUS

K894622 · Bion Ent., Ltd. · Microbiology
Oct 1989
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K894622 is an FDA 510(k) clearance for the VARICELLA ZOSTER VIRUS, a Antigen, Cf, (including Cf Control), Varicella-zoster (Class II — Special Controls, product code GQW), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on October 24, 1989, 96 days after receiving the submission on July 20, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K894622 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date October 24, 1989
Days to Decision 96 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQW — Antigen, Cf, (including Cf Control), Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

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