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

    PMA: P050051 · Supplement: S052 · Decision Jun 22, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ARCHITECT AUSAB, Alinity i Anti-HBs
    PMA Number
    P050051
    Supplement Number
    S052
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 22, 2023
    Date Received
    May 26, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of a new fill line in existing manufacturing space.