BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

    K Number: K954202 · Decision Jun 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    5
    Review Days
    287

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    Basic Information

    Device Name
    PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
    K Number
    K954202
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Hemotec, Inc.
    Date Received
    September 7, 1995
    Decision Date
    June 20, 1996
    Product Code
    JPA
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Expedited Review
    Y
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JPA System, Multipurpose For In Vitro Coagulation Studies

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    Other Clearances by Medtronic Hemotec, Inc.

    K Number Device Name
    K944115 HEPARIN ASSAY CARTRIDGES AND CONTROLS
    K940426 MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
    K923594 CLOTTRAC COAGULATION CONTROL
    K922031 HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL