Cleared Traditional

SLIDEX STAPH-KIT

K923212 · Biomerieux Vitek, Inc. · Microbiology
Sep 1992
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K923212 is an FDA 510(k) clearance for the SLIDEX STAPH-KIT, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 28, 1992, 89 days after receiving the submission on July 1, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K923212 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1992
Decision Date September 28, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JWX — Kit, Screening, Staphylococcus Aureus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660