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

    PMA: P060005 · Supplement: S014 · Decision Mar 29, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    IMMULITE / IMMULITE 1000 Free PSA, IMMULITE 2000 Free PSA
    PMA Number
    P060005
    Supplement Number
    S014
    Advisory Committee
    Immunology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 29, 2022
    Date Received
    February 28, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Implementation of a change to the physical state of a raw material.