FDA PMA

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Номер PMA: P230009 · 2026-09-16

ЗаявительGuardant Health, Inc.

Дата решения2026-09-16

Номер PMAP230009

Код продуктаPHP

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетMG

Описание устройства

System, colorectal neoplasia, DNA methylation and hemoglobin detection is the device name listed in this FDA 510(k) record. The listed applicant is Guardant Health, Inc.. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code PHP. It was reviewed by the MG advisory panel.

Часто задаваемые вопросы

What is the System, colorectal neoplasia, DNA methylation and hemoglobin detection?

System, colorectal neoplasia, DNA methylation and hemoglobin detection is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Guardant Health, Inc..

When did System, colorectal neoplasia, DNA methylation and hemoglobin detection receive FDA 510(k) clearance?

The clearance date for System, colorectal neoplasia, DNA methylation and hemoglobin detection can be found in the official FDA records.

Who is the listed applicant for System, colorectal neoplasia, DNA methylation and hemoglobin detection?

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

What is the FDA product code for System, colorectal neoplasia, DNA methylation and hemoglobin detection?

The FDA product code for System, colorectal neoplasia, DNA methylation and hemoglobin detection is PHP.

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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Официальный источник

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