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

    ERYTHROPOIETIN ENZYME IMMUNOASSAY

    K Number: K882686 · Decision Dec 20, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    173

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    Basic Information

    Device Name
    ERYTHROPOIETIN ENZYME IMMUNOASSAY
    K Number
    K882686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Amgen, Inc.
    Date Received
    June 30, 1988
    Decision Date
    December 20, 1988
    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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