FDA 510(k)

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

Número K: K183031 · 2019-01-11

Data da decisão2019-01-11

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/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 2019-01-11 under 510(k) number K183031. 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 Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)?

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Biomerieux S.A.. The 510(k) number is K183031.

When did ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) receive FDA 510(k) clearance?

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) received FDA 510(k) clearance on 2019-01-11, under 510(k) number K183031.

Who is the listed applicant for ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/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 Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)?

The FDA product code for ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) is JWY.

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Fonte oficial

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