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

    NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

    K Number: K202304 · Decision Jul 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    334

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    Basic Information

    Device Name
    NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
    K Number
    K202304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6080
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nyu Langone Medical Center
    Date Received
    August 14, 2020
    Decision Date
    July 14, 2021
    Product Code
    PZM
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    Y

    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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