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510(k) Data Aggregation

    K Number
    K001177
    Date Cleared
    2000-11-13

    (216 days)

    Product Code
    Regulation Number
    866.3110
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

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