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

    RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN

    K Number: K840103 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    31

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    Basic Information

    Device Name
    RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN
    K Number
    K840103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Techniclone Intl.
    Date Received
    January 10, 1984
    Decision Date
    February 10, 1984
    Product Code
    JHR
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JHR Radioimmunoassay, Immunoglobulins (D, E)

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