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

    ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III

    K Number: K894425 · Decision Aug 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    39
    Applicant Total
    42
    Review Days
    17

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    Basic Information

    Device Name
    ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
    K Number
    K894425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Control Systems, Inc.
    Date Received
    July 17, 1989
    Decision Date
    August 3, 1989
    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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