Cleared Traditional

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ?g/mL)

K212243 · bioMerieux, Inc. · Microbiology

Aug 2022

Decision

385d

Days

Class 2

Risk

About This 510(k) Submission

K212243 is an FDA 510(k) clearance for the VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ?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 8, 2022, 385 days after receiving the submission on July 19, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K212243 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2021
Decision Date	August 08, 2022
Days to Decision	385 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