Cleared Traditional

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ?g/mL)

K201675 · bioMerieux, Inc. · Microbiology

Jul 2021

Decision

385d

Days

Class 2

Risk

About This 510(k) Submission

K201675 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ?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 July 9, 2021, 385 days after receiving the submission on June 19, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K201675 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2020
Decision Date	July 09, 2021
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