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

    Immunocytochemistry Assay, P16/Ki-67

    PMA: P190024 · Supplement: S010 · Decision Aug 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunocytochemistry Assay, P16/Ki-67
    Trade Name
    CINtec PLUS Cytology
    PMA Number
    P190024
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    QKF
    Generic Name
    Immunocytochemistry assay, p16/Ki-67
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2023
    Date Received
    August 1, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of two contract manufacturers as approved suppliers of parts/components.

    Classifications

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

    Product Code Device Name
    QKF Immunocytochemistry Assay, P16/Ki-67