Cleared Traditional

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

K210287 · bioMerieux, Inc. · Microbiology

Oct 2021

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K210287 is an FDA 510(k) clearance for the VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 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 October 28, 2021, 268 days after receiving the submission on February 2, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K210287 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 2021
Decision Date	October 28, 2021
Days to Decision	268 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