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    K Number
    K173127
    Device Name
    skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
    Manufacturer
    Skyla Corporation H.S.P.B.
    Date Cleared
    2018-09-25

    (361 days)

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

    Skyla Corporation H.S.P.B.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood. The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus. This system is intended for clinical laboratory and point-of-care use. This test is not for screening or diagnosis of diabetes.
    Device Description
    The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.
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