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510(k) Data Aggregation

    K Number
    K050983
    Device Name
    IRMA TRUPOINT CREATININE CONTROL KIT
    Date Cleared
    2005-05-16

    (27 days)

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

    INTERNATIONAL TECHNIDYNE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IRMA TRUpoint™ Creatinine Control Kit is for use on the IRMA TRUpoint™ Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System. For in vitro Diagnostic Use Only
    Device Description
    The Creatinine Control Kit includes creatinine control materials at two levels for monitoring the IRMA analyzer performance at different points in the range of intended clinical utility. The control materials are packaged in capped luer lock syringes, each containing 1.5 ml of solution. The syringes are in turn packaged in pouches. Three (3) pouches/syringes for low level and three (3) pouches/syringes for high level are packaged in a box. The Cr control is an aqueous based solution of creatinine and sucrose. This control contains no human or biological materials.
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