Cleared Traditional

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 ?g/mL)

K250274 · Biomerieux S.A. · Microbiology
Apr 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250274 is an FDA 510(k) clearance for the ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 ?g/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 April 30, 2025, 90 days after receiving the submission on January 30, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K250274 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2025
Decision Date April 30, 2025
Days to Decision 90 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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