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

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    PMA: P980024 · Supplement: S009 · Decision Dec 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Nucleic Acid Or Serum
    Trade Name
    PATHVYSION HER-2 DNA PROBE KIT
    PMA Number
    P980024
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MVD
    Generic Name
    SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 26, 2012
    Date Received
    November 15, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEAD MIXING SYSTEM AND VALIDATE THE MIXING PROCESS IN THE MANUFACTURE OF THE HYBRIDIZATION BUFFER, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.

    Classifications

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

    Product Code Device Name
    MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum