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510(k) Data Aggregation

    K Number
    K011068
    Manufacturer
    Date Cleared
    2002-04-11

    (367 days)

    Product Code
    Regulation Number
    866.5100
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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