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

    I-STAT PROTHROMBIN TIME TEST

    K Number: K020355 · Decision May 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    7
    Review Days
    99

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    Basic Information

    Device Name
    I-STAT PROTHROMBIN TIME TEST
    K Number
    K020355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Stat Corporation
    Date Received
    February 4, 2002
    Decision Date
    May 14, 2002
    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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