Cleared Traditional

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ?g/mL)

K211630 · bioMerieux, Inc. · Microbiology

Aug 2021

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K211630 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ?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 August 30, 2021, 95 days after receiving the submission on May 27, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K211630 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2021
Decision Date	August 30, 2021
Days to Decision	95 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