FDA 510(k)

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

Número K: K191953 · 2019-08-22

Data da decisão2019-08-22

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2019-08-22 under 510(k) number K191953. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-08-22. The listed applicant is Biomerieux S.A.. The 510(k) number is K191953.

When did ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) receive FDA 510(k) clearance?

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) received FDA 510(k) clearance on 2019-08-22, under 510(k) number K191953.

Who is the listed applicant for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

The FDA 510(k) record lists Biomerieux S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)?

The FDA product code for ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) is JWY.

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Outros registros que listam Biomerieux S.A. como candidato(a)

K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)K183031ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

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Fonte oficial

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