Cleared Traditional

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ?g/mL)

K214023 · bioMerieux, Inc. · Microbiology

Apr 2022

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K214023 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ?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 April 14, 2022, 113 days after receiving the submission on December 22, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K214023 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2021
Decision Date	April 14, 2022
Days to Decision	113 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