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    K Number
    K170147
    Device Name
    Lucica Glycated Albumin-L
    Manufacturer
    ASAHI KASEI PHARMA CORPORATION
    Date Cleared
    2017-10-12

    (268 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASAHI KASEI PHARMA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lucica® Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.
    Device Description
    Lucica® Glycated Albumin-L contains two glycated albumin reagents and two albumin reagents. The kit employs liquid reagents that require no preparation.
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