Cleared Traditional

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

K211136 · bioMerieux, Inc. · Microbiology

Jun 2021

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K211136 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 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 June 14, 2021, 59 days after receiving the submission on April 16, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K211136 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2021
Decision Date	June 14, 2021
Days to Decision	59 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