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PMA de la FDA

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Número de PMA: P130001 · 2025-03-19

SolicitanteNew Day Diagnostics, LLC
Fecha de decisión2025-03-19
Número PMAP130001
Código de productoPHP
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorPA

Resumen del dispositivo

System, colorectal neoplasia, DNA methylation and hemoglobin detection is the device name listed in this FDA 510(k) record. The listed applicant is New Day Diagnostics, LLC. It received FDA 510(k) clearance on 2025-03-19. The device is classified under product code PHP. It was reviewed by the PA advisory panel.

Preguntas frecuentes

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 2025-03-19. The listed applicant is New Day Diagnostics, LLC.

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 New Day Diagnostics, LLC 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.

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Fuente oficial

Ver en la base de datos de la FDA →

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