Cleared Traditional

RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA

K910304 · Vitek Systems, Inc. · Microbiology
Jul 1991
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K910304 is an FDA 510(k) clearance for the RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA, a Gram Positive Identification Panel (Class I — General Controls, product code LQL), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 26, 1991, 183 days after receiving the submission on January 24, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K910304 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1991
Decision Date July 26, 1991
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQL — Gram Positive Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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