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510(k) Data Aggregation

    K Number
    DEN230051
    Device Name
    Myocene
    Manufacturer
    Date Cleared
    2025-01-17

    (540 days)

    Product Code
    Regulation Number
    882.1871
    Why did this record match?
    Applicant Name (Manufacturer) :

    Myocene

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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