ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)— 510(k) K250274

Clearance details

Applicant

Biomerieux S.A.

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2025-01-30

Decision date

2025-04-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marcy-L'Etoile, FR

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• K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)2019-05-01