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510(k) Data Aggregation

    K Number
    K061412
    Device Name
    THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
    Manufacturer
    THERMO ELECTRON CORP.
    Date Cleared
    2007-03-23

    (305 days)

    Product Code
    JFY
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMO ELECTRON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro quantitative determination of Creatinine in human serum, plasma or urine. Creatinine determinations are used in the diagnosis and treatment of renal impairment, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
    Device Description
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