Cleared Traditional

VITEK COMPACT PRO

K234012 · bioMerieux, Inc. · Microbiology
Mar 2025
Decision
451d
Days
Class 2
Risk

About This 510(k) Submission

K234012 is an FDA 510(k) clearance for the VITEK COMPACT PRO, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 14, 2025, 451 days after receiving the submission on December 19, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K234012 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2023
Decision Date March 14, 2025
Days to Decision 451 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1645

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