BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)

    K Number: K250003 · Decision Aug 29, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    239

    Basic Information

    Device Name
    GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
    K Number
    K250003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6080
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geneseeq Technology, Inc.
    Date Received
    January 2, 2025
    Decision Date
    August 29, 2025
    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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