Cleared Traditional

RSV-MAB TEST

K912842 · Gull Laboratories, Inc. · Microbiology
Dec 1991
Decision
166d
Days
Class 1
Risk

About This 510(k) Submission

K912842 is an FDA 510(k) clearance for the RSV-MAB TEST, a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I — General Controls, product code LKT), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 9, 1991, 166 days after receiving the submission on June 26, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K912842 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1991
Decision Date December 09, 1991
Days to Decision 166 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3480

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