FDA 510(k)

EasyScreen Gastrointestinal Parasite Detection Kit

Номер K: K232672 · 2024-05-29

Дата решения2024-05-29

Код продуктаPCH

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

EasyScreen Gastrointestinal Parasite Detection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Signatures Limited. It received FDA 510(k) clearance on 2024-05-29 under 510(k) number K232672. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the EasyScreen Gastrointestinal Parasite Detection Kit?

EasyScreen Gastrointestinal Parasite Detection Kit is a medical device that received FDA 510(k) clearance on 2024-05-29. The listed applicant is Genetic Signatures Limited. The 510(k) number is K232672.

When did EasyScreen Gastrointestinal Parasite Detection Kit receive FDA 510(k) clearance?

EasyScreen Gastrointestinal Parasite Detection Kit received FDA 510(k) clearance on 2024-05-29, under 510(k) number K232672.

Who is the listed applicant for EasyScreen Gastrointestinal Parasite Detection Kit?

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

What is the FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit?

The FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit is PCH.

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: PCH)

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251721Xpert GI PanelCepheid K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH K251868Panther Fusion GI Bacterial AssayHologic K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.

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