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510(k) Data Aggregation

    K Number
    K980908
    Device Name
    LACTATE PRO SYSTEM
    Manufacturer
    KDK CORP.
    Date Cleared
    1998-09-11

    (185 days)

    Product Code
    KHP
    Regulation Number
    862.1450
    Why did this record match?
    Applicant Name (Manufacturer) :

    KDK CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.
    Device Description
    The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.
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