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PMA de la FDA

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

Número de PMA: P190022 · 2025-07-25

SolicitanteOpko Health, Inc.
Fecha de decisión2025-07-25
Número PMAP190022
Código de productoQRF
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorIM

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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