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

    ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I

    K Number: K893784 · Decision Jun 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    42
    Review Days
    32

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    Basic Information

    Device Name
    ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
    K Number
    K893784
    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
    May 22, 1989
    Decision Date
    June 23, 1989
    Product Code
    GIZ
    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
    GIZ Plasma, Control, Normal

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