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

    CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

    K Number: K894943 · Decision Oct 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    68

    Basic Information

    Device Name
    CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
    K Number
    K894943
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    AMGEN, INC.
    Date Received
    August 3, 1989
    Decision Date
    October 10, 1989
    Product Code
    GGT
    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
    GGT Assay, Erythropoietin

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