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

    PGDx elio plasma focus Dx

    K Number: DEN230046 · Decision Aug 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    398

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    Basic Information

    Device Name
    PGDx elio plasma focus Dx
    K Number
    DEN230046
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6085
    Medical Specialty
    Pathology
    Decision
    Unknown
    Applicant
    Personal Genome Diagnostics, Inc.
    Date Received
    June 30, 2023
    Decision Date
    August 1, 2024
    Product Code
    SBY
    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
    SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids