FDA 510(k)

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Номер K: K230675 · 2024-06-20

Дата решения2024-06-20

Код продуктаSAN

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

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 Specific Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K230675. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

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 2024-06-20. The listed applicant is Specific Diagnostics, LLC. The 510(k) number is K230675.

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 2024-06-20, under 510(k) number K230675.

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

The FDA 510(k) record lists Specific Diagnostics, LLC 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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: SAN)

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.K253316PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp.K253573ASTar BC G- KitQ-Linea AB K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K221688ASTar BC G- Kit и ASTar ИнструментQ-Linea AB

Официальный источник

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