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510(k) Data Aggregation

    K Number
    K970248
    Device Name
    CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
    Date Cleared
    1997-02-11

    (20 days)

    Product Code
    Regulation Number
    862.1415
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANYON DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CANTROL Serum Iron and Total Iron Binding Capacity test system provides a simple, but effective, method for quantitating the level of serum iron and total iron binding capacity in human blood serum.
    Device Description
    In the CANTROL Serum Iron procedure Iron is released from its carner, transferrin, by an acidic reagent containing hydroxylamine and thiourea which reduces the iron to its ferrous state. A chromogen reagent, ferene, reacts with the ferrous iron to produce a colored complex, the color of which is proportional to the quantity of Iron in the test sample. Color of the reaction is measured spectrophotometrically. Total Iron Binding Capacity analysis uses the same color reaction to test serum samples which have been saturated with iron by use of an ion exchange resin in the presence of ferric ammonium citrate, prior to the iron determination. The bound iron remaining in the serum after treatment with the resin compound is the Total Iron Binding Capacity.
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    K Number
    K964640
    Device Name
    CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92
    Date Cleared
    1996-12-13

    (24 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANYON DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CANTROL Iron /TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.
    Device Description
    CANTROL Iron/TIBC Controls are manufactured from human serum and provide a means for monitoring Serum Iron and TIBC testing procedures by the use of control materials in a manner identical to patient samples. CANTROL Iron/TIBC Control materials are equivalent to other human serum based chemistry control products.
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