BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    ALLOMAP MOLECULAR EXPRESSION TESTING

    K Number: DEN080007 · Decision Aug 26, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    11

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    Basic Information

    Device Name
    ALLOMAP MOLECULAR EXPRESSION TESTING
    K Number
    DEN080007
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.1163
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Xdx
    Date Received
    August 15, 2008
    Decision Date
    August 26, 2008
    Product Code
    OJQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OJQ Cardiac Allograft Gene Expression Profiling Test System

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