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

    EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)

    K Number: K902639 · Decision Aug 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    58
    Review Days
    69

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    Basic Information

    Device Name
    EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
    K Number
    K902639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Incstar Corp.
    Date Received
    June 14, 1990
    Decision Date
    August 22, 1990
    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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