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FDA PMA

System, colorectal neoplasia, DNA methylation and hemoglobin detection

PMA Number: P130017 · 2026-06-09

ApplicantExact Sciences Corporation
Decision Date2026-06-09
PMA NumberP130017
Product CodePHP
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

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 2026-06-09. The device is classified under product code PHP. It was reviewed by the PA advisory panel.

Frequently Asked Questions

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 2026-06-09. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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