BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    PMA: P230001 · Supplement: S009 · Decision Sep 15, 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
    S009
    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
    Approved
    Decision Code
    APPR
    Decision Date
    September 15, 2025
    Date Received
    July 16, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Submission is approved.

    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