Cleared Traditional

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ?g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ?g/mL), VITEK 2 AST-GP Moxifloxacin

K220803 · bioMerieux, Inc. · Microbiology

Jan 2023

Decision

315d

Days

Class 2

Risk

About This 510(k) Submission

K220803 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ?g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ?g/mL), VITEK 2 AST-GP Moxifloxacin, 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 January 27, 2023, 315 days after receiving the submission on March 18, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K220803 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2022
Decision Date	January 27, 2023
Days to Decision	315 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