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

    QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY

    K Number: K931666 · Decision Jul 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    79
    Review Days
    105

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    Basic Information

    Device Name
    QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
    K Number
    K931666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R&D Systems, Inc.
    Date Received
    April 6, 1993
    Decision Date
    July 20, 1993
    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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