Cleared Traditional

VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD

K925916 · Biomerieux Vitek, Inc. · Chemistry
Mar 1993
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K925916 is an FDA 510(k) clearance for the VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD, a Gram Positive Identification Panel (Class I — General Controls, product code LQL), 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 Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K925916 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 Chemistry (CH)
Summary Summary PDF

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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