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510(k) Data Aggregation

    K Number
    K061991
    Device Name
    PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2007-02-23

    (225 days)

    Product Code
    GHR
    Regulation Number
    864.5700
    Why did this record match?
    Product Code :

    GHR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plateletworks Arachidonic Acid (PW-ACA) is an in vitro diagnostic screening test on whole blood for the qualitative determination of platelet inhibition by aspirin which inhibit arachidonic acid induced platelet aggregation. The change in platelet count due to activation and aqqreqation of functional platelets is measured using an electronic impedance-base cell counter.
    Device Description
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