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510(k) Data Aggregation

    K Number
    K984119
    Device Name
    WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    1999-01-15

    (58 days)

    Product Code
    CFM
    Regulation Number
    862.1410
    Why did this record match?
    Product Code :

    CFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis, and chronic renal disease.
    Device Description
    The Wako L-type Fe test is an in vitro diagnostic assay for the quantitative determination of iron in serum. When a sample is mixed with the Buffer, serum protein is denatured by the action of surfactant contained in the Buffer and transferrin-bound iron is liberated. All the Fe" ions released are reduced to Fe2+ by L-ascorbate and form a chelate with bathophenanthroline disulfonic acid disodium salt. The serum iron can be determined by measuring the absorbance of the red chelate solution.
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    K Number
    K981581
    Device Name
    IRON
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1998-06-08

    (35 days)

    Product Code
    CFM
    Regulation Number
    862.1410
    Why did this record match?
    Product Code :

    CFM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
    Device Description
    Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.
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