Cleared Traditional

VITEK RAPID CALL-GRAM NEGATIV IDENT CARD

K925915 · Biomerieux Vitek, Inc. · Microbiology
Mar 1993
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K925915 is an FDA 510(k) clearance for the VITEK RAPID CALL-GRAM NEGATIV IDENT CARD, a Gram Negative Identification Panel (Class I — General Controls, product code LQM), submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 23, 1993, 120 days after receiving the submission on November 23, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K925915 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1992
Decision Date March 23, 1993
Days to Decision 120 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LQM — Gram Negative Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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