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

    TAS PTONE

    K Number: K955843 · Decision Mar 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    8
    Review Days
    83

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    Basic Information

    Device Name
    TAS PTONE
    K Number
    K955843
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Diagnostic Services
    Date Received
    December 26, 1995
    Decision Date
    March 18, 1996
    Product Code
    GJS
    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
    GJS Test, Time, Prothrombin

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