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    K Number
    K954202
    Device Name
    PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
    Manufacturer
    MEDTRONIC HEMOTEC, INC.
    Date Cleared
    1996-06-20

    (287 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC HEMOTEC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The tests presented in this application use an instrument platform and assay cartridges that have been used in cardiopulmonary bypass surgery since 1989. The instrument and assay cartridges have proven to be sturdy, reliable, and effective. The instrument and cartridges are designed for the detection of clot formation. The present series of Platelet Function Tests also rely on the detection of clot formation, thus there is not an extension of the basic technology. The basic principles of the instrument and cartridges do not change.
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