Cleared Traditional

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 ?g/mL)

K232967 · bioMerieux, Inc. · Microbiology

Jun 2024

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K232967 is an FDA 510(k) clearance for the VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 ?g/mL), a Susceptibility Test Plate, Antifungal (Class II — Special Controls, product code NGZ), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 12, 2024, 265 days after receiving the submission on September 21, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K232967 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2023
Decision Date	June 12, 2024
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NGZ — Susceptibility Test Plate, Antifungal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640
Definition	The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.