FDA 510(k)

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

Número K: K232395 · 2023-10-05

Data da decisão2023-10-05

Código do produtoJWY

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K232395. 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® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Biomérieux. The 510(k) number is K232395.

When did ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD receive FDA 510(k) clearance?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD received FDA 510(k) clearance on 2023-10-05, under 510(k) number K232395.

Who is the listed applicant for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

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

What is the FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

The FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is JWY.

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Fonte oficial

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