BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    PMA: P230009 · Supplement: S009 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
    Trade Name
    Shield
    PMA Number
    P230009
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    PHP
    Generic Name
    System, colorectal neoplasia, DNA methylation and hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Medical Genetics
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 30, 2025
    Date Received
    September 30, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for addition of a secondary vendor and manufacturing process changes

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHP System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection