Cleared Traditional

VZV IGM TEST

K911301 · Gull Laboratories, Inc. · Microbiology
Jul 1991
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K911301 is an FDA 510(k) clearance for the VZV IGM 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 July 17, 1991, 114 days after receiving the submission on March 25, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K911301 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1991
Decision Date July 17, 1991
Days to Decision 114 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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