Cleared Traditional

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

K222073 · bioMerieux, Inc. · Microbiology

Feb 2023

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K222073 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 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 February 9, 2023, 210 days after receiving the submission on July 14, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K222073 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2022
Decision Date	February 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