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

    PMA: P050028 · Supplement: S008 · Decision Aug 30, 2010
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
    PMA Number
    P050028
    Supplement Number
    S008
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 30, 2010
    Date Received
    August 5, 2010
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    SCALE-UP OF A MANUFACTURING PROCESS.