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510(k) Data Aggregation

    K Number
    K010818

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2001-05-24

    (66 days)

    Product Code
    Regulation Number
    880.6760
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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