FDA 510(k)

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

Número K: K190154 · 2019-05-01

Data da decisão2019-05-01

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 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 2019-05-01 under 510(k) number K190154. 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 Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Biomerieux S.A.. The 510(k) number is K190154.

When did ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) receive FDA 510(k) clearance?

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) received FDA 510(k) clearance on 2019-05-01, under 510(k) number K190154.

Who is the listed applicant for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 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 Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)?

The FDA product code for ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) is JWY.

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Fonte oficial

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