FDA PMA

Multi-analyte test system with algorithmic analysis for detection of prostate cancer

Номер PMA: P190022 · 2025-07-25

ЗаявительOpko Health, Inc.

Дата решения2025-07-25

Номер PMAP190022

Код продуктаQRF

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетIM

Описание устройства

Multi-analyte test system with algorithmic analysis for detection of prostate cancer is the device name listed in this FDA 510(k) record. The listed applicant is Opko Health, Inc.. It received FDA 510(k) clearance on 2025-07-25. The device is classified under product code QRF. It was reviewed by the IM advisory panel.

Часто задаваемые вопросы

What is the Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

Multi-analyte test system with algorithmic analysis for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Opko Health, Inc..

When did Multi-analyte test system with algorithmic analysis for detection of prostate cancer receive FDA 510(k) clearance?

The clearance date for Multi-analyte test system with algorithmic analysis for detection of prostate cancer can be found in the official FDA records.

Who is the listed applicant for Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

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

What is the FDA product code for Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

The FDA product code for Multi-analyte test system with algorithmic analysis for detection of prostate cancer is QRF.

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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