ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)— 510(k) K191953

Clearance details

Applicant

Biomerieux S.A.

Product code

Code JWY

Device class

Class 2

Regulation

21 CFR 866.1640

Advisory panel

Microbiology

Date received

2019-07-22

Decision date

2019-08-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marcy-L'Etoile, FR

• K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)2026-04-21
• K260696 — MTS Gepotidacin 0.016-256 µg/mL2026-04-17
• K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL2025-10-02
• K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL2025-09-25
• K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL2025-09-05

• K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)2025-04-30
• K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)2021-11-12
• K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)2019-11-26
• K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)2019-09-27
• K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)2019-05-01

• Z-0849-2023 — ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927Class II·Ongoing·Biomerieux Inc·20221109
• Z-2226-2021 — ETEST IMIPENEM RELEBACTAM. in vitro diagnosticClass II·Terminated·Biomerieux Inc·20210624

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191953.