Cleared Traditional

VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)

K222378 · bioMerieux, Inc. · Microbiology

Jun 2023

Decision

325d

Days

Class 2

Risk

About This 510(k) Submission

K222378 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL), 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 June 26, 2023, 325 days after receiving the submission on August 5, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K222378 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2022
Decision Date	June 26, 2023
Days to Decision	325 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