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

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    PMA: P230001 · Supplement: S011 · Decision Oct 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
    Trade Name
    ColoSense®
    PMA Number
    P230001
    Supplement Number
    S011
    Device Class
    FDA Class 3
    Product Code
    SBB
    Generic Name
    System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 24, 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 modifying the concentration of a reagent used in the manufacturing process of QC materials and the qualification of an alternate reagent supplier

    Classifications

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

    Product Code Device Name
    SBB System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection