Cleared Traditional

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 ?g/mL)

K234000 · bioMerieux, Inc. · Microbiology

Mar 2024

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K234000 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 ?g/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 March 11, 2024, 84 days after receiving the submission on December 18, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K234000 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2023
Decision Date	March 11, 2024
Days to Decision	84 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