Cleared Traditional

K222430 - VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (FDA 510(k) Clearance)

K222430 · Biomerieux Sa, Inc. · Microbiology device

Mar 2023

Decision

210d

Days

Class 2

Risk

K222430 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin. This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).

Submitted by Biomerieux Sa, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 9, 2023, 210 days after receiving the submission on August 11, 2022.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K222430 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 2022
Decision Date	March 09, 2023
Days to Decision	210 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