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510(k) Data Aggregation

    K Number
    K010052
    Manufacturer
    Date Cleared
    2001-03-19

    (70 days)

    Product Code
    Regulation Number
    862.1113
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER

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