Cleared Traditional

K213241 - VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (FDA 510(k) Clearance)

K213241 · bioMerieux, Inc. · Microbiology device

Feb 2022

Decision

148d

Days

Class 2

Risk

K213241 is an FDA 510(k) clearance for the VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole. This device is classified as 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 25, 2022, 148 days after receiving the submission on September 30, 2021.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K213241 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2021
Decision Date	February 25, 2022
Days to Decision	148 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