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510(k) Data Aggregation

    K Number
    K011596
    Device Name
    UREA NITROGEN (BUN) LIQUID REAGENT
    Manufacturer
    JAS DIAGNOSTIC, INC.
    Date Cleared
    2001-07-17

    (54 days)

    Product Code
    CDQ
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    JAS DIAGNOSTIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for the In Vitro, quantitative determination of urea nitrogen (BUN) in human serum on automated chemistry analyzers. Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
    Device Description
    This Reagent is intended for the in vitro quantitative determination of urea nitrogen in human serum.
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