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

    PMA: P050028 · Supplement: S005 · Decision Jul 30, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
    PMA Number
    P050028
    Supplement Number
    S005
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 30, 2009
    Date Received
    July 2, 2009
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ELIMINATION OF FUNCTIONAL RELEASE TESTING FOR THE FINAL BULK MATERIALS PRIOR TO FILLING.