Cleared Traditional

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

K251579 · bioMerieux, Inc. · Microbiology

Aug 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K251579 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 ?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 August 21, 2025, 90 days after receiving the submission on May 23, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K251579 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2025
Decision Date	August 21, 2025
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