FDA 510(k)

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Número K: K260160 · 2026-07-08

Data da decisão2026-07-08

Código do produtoSAN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2026-07-08 under 510(k) number K260160. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is a medical device that received FDA 510(k) clearance on 2026-07-08. The listed applicant is bioMerieux, Inc.. The 510(k) number is K260160.

When did VITEK REVEAL GN AST Assay and VITEK REVEAL AST System receive FDA 510(k) clearance?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System received FDA 510(k) clearance on 2026-07-08, under 510(k) number K260160.

Who is the listed applicant for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

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 REVEAL GN AST Assay and VITEK REVEAL AST System?

The FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is SAN.

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Dispositivos Relacionados (Código: SAN)

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Fonte oficial

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