BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunocytochemistry Assay, P16/Ki-67

    PMA: P190024 · Supplement: S012 · Decision Jan 26, 2024
    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
    S012
    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
    Approved
    Decision Code
    APPR
    Decision Date
    January 26, 2024
    Date Received
    October 30, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

    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