Cleared Traditional

VITEK GRAM-NEGATIVE IDENTIFICATION CARD

K883558 · Vitek Systems, Inc. · Microbiology
Sep 1988
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K883558 is an FDA 510(k) clearance for the VITEK GRAM-NEGATIVE IDENTIFICATION CARD, a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 16, 1988, 28 days after receiving the submission on August 19, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K883558 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1988
Decision Date September 16, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSS — Kit, Identification, Enterobacteriaceae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660