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510(k) Data Aggregation

    K Number
    K112416
    Device Name
    CPK REAGENT
    Manufacturer
    VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD
    Date Cleared
    2011-11-09

    (79 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or plasma. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
    Device Description
    Vital Diagnostics CPK Reagent
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