Cleared Traditional

VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)

K202396 · bioMerieux, Inc. · Microbiology

Sep 2021

Decision

389d

Days

Class 2

Risk

About This 510(k) Submission

K202396 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 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 September 14, 2021, 389 days after receiving the submission on August 21, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K202396 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2020
Decision Date	September 14, 2021
Days to Decision	389 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