Cleared Traditional

MTS Piperacillin-tazobactam 0.016/4 - 256/4?g/mL

K211672 · Liofilchem S. R. L. · Microbiology
Oct 2021
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K211672 is an FDA 510(k) clearance for the MTS Piperacillin-tazobactam 0.016/4 - 256/4?g/mL, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi, IT). The FDA issued a Cleared decision on October 20, 2021, 141 days after receiving the submission on June 1, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K211672 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2021
Decision Date October 20, 2021
Days to Decision 141 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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