Cleared Traditional

BIOMERIEUX RSV DIRECT IF KIT

K912371 · Vitek Systems, Inc. · Microbiology
Sep 1991
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K912371 is an FDA 510(k) clearance for the BIOMERIEUX RSV DIRECT IF KIT, a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I — General Controls, product code LKT), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 23, 1991, 117 days after receiving the submission on May 29, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number K912371 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1991
Decision Date September 23, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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