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

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    PMA: P010007 · Supplement: S024 · Decision Oct 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
    Trade Name
    IMMULITE 2000 AFP
    PMA Number
    P010007
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    LOK
    Generic Name
    KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    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 the move of critical raw material operations of an internal supplier in-house to an internal company site.

    Classifications

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

    Product Code Device Name
    LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects