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510(k) Data Aggregation

    K Number
    K954402
    Manufacturer
    Date Cleared
    1996-05-22

    (245 days)

    Product Code
    Regulation Number
    868.1400
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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