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510(k) Data Aggregation

    K Number
    K082763
    Device Name
    DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
    Date Cleared
    2008-11-12

    (51 days)

    Product Code
    Regulation Number
    862.1665
    Why did this record match?
    Product Code :

    MZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diazyme Liquid Stable Enzymatic Sodium Assay is intended for the quantitative in vitro determination of sodium in serum. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
    Device Description
    Not Found
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    K Number
    K042189
    Device Name
    DIAZYME SODIUM ENZYMATIC ASSAY
    Date Cleared
    2004-10-07

    (56 days)

    Product Code
    Regulation Number
    862.1665
    Why did this record match?
    Product Code :

    MZU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum.
    Device Description
    Diazyme's Sodium Enzymatic assay is proven to be equivalent to ISE method but more user friendly in automated analyzers. Sodium is determined enzymatically via sodium dependent ß-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration.
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