Cleared Traditional

VZV TEST

K875358 · Gull Laboratories, Inc. · Microbiology
Mar 1988
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K875358 is an FDA 510(k) clearance for the VZV TEST, a Antiserum, Cf, Varicella-zoster (Class II — Special Controls, product code GQX), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 31, 1988, 91 days after receiving the submission on December 31, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K875358 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1987
Decision Date March 31, 1988
Days to Decision 91 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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