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510(k) Data Aggregation

    K Number
    K993131
    Device Name
    NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
    Manufacturer
    PRIMUS, INC.
    Date Cleared
    2000-05-22

    (245 days)

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

    PRIMUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measurement of Glycohemoglobin in blood. In vitro diagnostic use only. NycoCard HbA1c is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus.
    Device Description
    Not Found
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