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

    CLP PROTHROMBIN TIME TEST

    K Number: K880566 · Decision Mar 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    27
    Review Days
    42

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    Basic Information

    Device Name
    CLP PROTHROMBIN TIME TEST
    K Number
    K880566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Creative Laboratory Products, Inc.
    Date Received
    February 10, 1988
    Decision Date
    March 23, 1988
    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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