FDA 510(k)

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

Номер K: K211815 · 2024-04-02

Дата решения2024-04-02

Код продуктаSAN

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is the device name listed in this FDA 510(k) record. The listed applicant is Affinity Biosensors. It received FDA 510(k) clearance on 2024-04-02 under 510(k) number K211815. 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 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is a medical device that received FDA 510(k) clearance on 2024-04-02. The listed applicant is Affinity Biosensors. The 510(k) number is K211815.

When did LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System receive FDA 510(k) clearance?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System received FDA 510(k) clearance on 2024-04-02, under 510(k) number K211815.

Who is the listed applicant for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

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

What is the FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

The FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale 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 K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC

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