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510(k) Data Aggregation

    K Number
    K080468
    Device Name
    LIASYS WITH MODELS LIASYS
    Date Cleared
    2008-07-25

    (155 days)

    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMS S.R.L. ANALYZER MEDICAL SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides the In Vitro diagnostic quantitative measurements for glucose, urea nitrogen, creatinine and AST in serum, and for sodium, potassium and chloride in scrum. Other various chemistry assays may be adaptable to this instrument. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Urea Nitrogen measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Measurements of Creatinine are used in the diagnosis and treatment of muscle diseases and endocrine disorders. Aspartate amino transferase (AST) quantitative measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and 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.
    Device Description
    The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry.
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