Cleared Traditional

K223478 - VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL) (FDA 510(k) Clearance)

Also includes:

VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL) VITEK® 2 AST-GN Plazomicin

K223478 · bioMerieux, Inc. · Microbiology device

Feb 2023

Decision

90d

Days

Class 2

Risk

K223478 is an FDA 510(k) clearance for the VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL). This device is classified as 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 February 16, 2023, 90 days after receiving the submission on November 18, 2022.

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

Submission Details

510(k) Number	K223478 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 18, 2022
Decision Date	February 16, 2023
Days to Decision	90 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