Cleared Traditional

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

K190154 · Biomerieux S.A. · Microbiology
May 2019
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K190154 is an FDA 510(k) clearance for the ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL), a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Biomerieux S.A. (Marcy-L'?toile, FR). The FDA issued a Cleared decision on May 1, 2019, 91 days after receiving the submission on January 30, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K190154 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2019
Decision Date May 01, 2019
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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