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510(k) Data Aggregation

    K Number
    DEN240035
    Device Name
    ConcizuTrace™ ELISA
    Manufacturer
    Randox Laboratories Ltd
    Date Cleared
    2025-05-22

    (325 days)

    Product Code
    SES
    Regulation Number
    864.7298
    Why did this record match?
    Product Code :

    SES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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