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510(k) Data Aggregation

    K Number
    K983617
    Device Name
    25-HYDROXYVITAMIN D 125I RIA KIT
    Manufacturer
    DIASORIN, INC.
    Date Cleared
    1998-11-16

    (32 days)

    Product Code
    LCI
    Regulation Number
    862.2050
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    Product Code :

    LCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR IN VITRO DIAGNOSTIC USE. This kit intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population.
    Device Description
    Immunoassay kit for quantitative determination of 25-hydroxyvitamin D
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