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

    MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay

    K Number: DEN170058 · Decision Nov 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    51

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    Basic Information

    Device Name
    MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
    K Number
    DEN170058
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6080
    Medical Specialty
    Pathology
    Decision
    Unknown
    Applicant
    Memorial Sloan-Kettering Cancer Center
    Date Received
    September 25, 2017
    Decision Date
    November 15, 2017
    Product Code
    PZM
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZM Next Generation Sequencing Based Tumor Profiling Test

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