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

    CLP ABNORMAL COAGULATION CONTROL

    K Number: K881510 · Decision May 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    39
    Applicant Total
    27
    Review Days
    25

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    Basic Information

    Device Name
    CLP ABNORMAL COAGULATION CONTROL
    K Number
    K881510
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Creative Laboratory Products, Inc.
    Date Received
    April 11, 1988
    Decision Date
    May 6, 1988
    Product Code
    GGC
    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
    GGC Control, Plasma, Abnormal

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