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

    DSL ERYTHROPOIETIN (DSL # 1100)

    K Number: K903492 · Decision Oct 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    19
    Applicant Total
    94
    Review Days
    84

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    Basic Information

    Device Name
    DSL ERYTHROPOIETIN (DSL # 1100)
    K Number
    K903492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7250
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    August 3, 1990
    Decision Date
    October 26, 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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