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510(k) Data Aggregation

    K Number
    K172232
    Device Name
    LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
    Manufacturer
    AMS Diagnostics
    Date Cleared
    2019-06-12

    (687 days)

    Product Code
    JGS, CEM, CGX, CGZ, JJE
    Regulation Number
    862.1665
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    Applicant Name (Manufacturer) :

    AMS Diagnostics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.
    Device Description
    The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.
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