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

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

    PMA: P940004 · Supplement: S001 · Decision Aug 1, 2000
    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
    INFORM HER-2/NEU
    PMA Number
    P940004
    Supplement Number
    S001
    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
    August 1, 2000
    Date Received
    July 10, 2000
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    RAW MATERIAL SUBSTITUTION OF REPLACING NONIDET P-40, RAW MATERIAL WITH IGEPAL CA-630, AND CHANGES FOR THE USE OF DRY POWDERS OR SOLUTIONS THAT ARE PURCHASED RATHER THAN MANUFACTURED WHILE KEEPING THE FINAL FORMULATION AND SPECIFICATIONS THE SAME.

    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