When did VITEK 2 AST-Yeast Anidulafungin ( = 8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Yeast Anidulafungin ( = 8 µg/mL) received FDA 510(k) clearance on 2024-06-07, under 510(k) number K232963.

FDA 510(k)

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

Número K: K232963 · 2024-06-07

RequerentebioMerieux, Inc.

Data da decisão2024-06-07

Código do produtoNGZ

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K232963. The device is classified under product code NGZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)?

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is bioMerieux, Inc.. The 510(k) number is K232963.

When did VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) received FDA 510(k) clearance on 2024-06-07, under 510(k) number K232963.

Who is the listed applicant for VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)?

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

What is the FDA product code for VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)?

The FDA product code for VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) is NGZ.

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Outros registros que listam bioMerieux, Inc. como candidato(a)

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Dispositivos Relacionados (Código: NGZ)

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Fonte oficial

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