Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033137
    Device Name
    POTENS +
    Manufacturer
    Date Cleared
    2003-12-08

    (69 days)

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

    WADA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    POTENS+ is an in vitro medical device to determine the coagulation profile of citrated human plasma specimens to be used by a medical professional in a laboratory setting. This profile includes Prothrombin Time (PT) derived Fibrinogen (FBG), and the International Normalization Ratio (INR). Prothrombin Time is used to determine the status of the extrinsic clotting pathway for Clotting Factors I, II, V, VII and X, and to assist in monitoring oral anticoagulants. Fibrinogen is used to diagnose disseminated intravascular coagulation (DIC), as a representation of acute disease - part of the "acute phase response," and it is an independent risk variable in heart attack and stroke prediction. INR is used to monitor the patients receiving anticoagulation therapy.
    Device Description
    Semi-automated system for in vitro coagulation studies, clot based and photo-optical.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1