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FDA PMA

System, colorectal neoplasia, DNA methylation and hemoglobin detection

Número do PMA: P230043 · 2026-08-03

RequerenteExact Sciences Corporation
Data da decisão2026-08-03
Número PMAP230043
Código do produtoPHP
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoPA

Resumo do dispositivo

System, colorectal neoplasia, DNA methylation and hemoglobin detection is the device name listed in this FDA 510(k) record. The listed applicant is Exact Sciences Corporation. It received FDA 510(k) clearance on 2026-08-03. The device is classified under product code PHP. It was reviewed by the PA advisory panel.

Perguntas frequentes

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 2026-08-03. The listed applicant is Exact Sciences Corporation.

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 Exact Sciences Corporation 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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Fonte oficial

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