Cleared Traditional

INFLUENZA MAB TEST/INFLUENZA A TEST

K913351 · Gull Laboratories, Inc. · Microbiology
Dec 1991
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K913351 is an FDA 510(k) clearance for the INFLUENZA MAB TEST/INFLUENZA A TEST, a Antisera, Cf, Influenza Virus A, B, C (Class I — General Controls, product code GNW), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 17, 1991, 144 days after receiving the submission on July 26, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number K913351 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1991
Decision Date December 17, 1991
Days to Decision 144 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GNW — Antisera, Cf, Influenza Virus A, B, C
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3330

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