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

    DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO

    K Number: K851127 · Decision May 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    253
    Review Days
    71

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    Basic Information

    Device Name
    DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
    K Number
    K851127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    March 19, 1985
    Decision Date
    May 29, 1985
    Product Code
    JPA
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    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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