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

    DIAGNON FERRITIN 125 I RIA KIT

    K Number: K830580 · Decision May 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    1
    Review Days
    71

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    Basic Information

    Device Name
    DIAGNON FERRITIN 125 I RIA KIT
    K Number
    K830580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Iagnon Corp.
    Date Received
    February 23, 1983
    Decision Date
    May 5, 1983
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DBF Ferritin, Antigen, Antiserum, Control

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