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

    RID PLATES & INTENSI. FOR HUMAN IGE ETC

    K Number: K771238 · Decision Jul 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    56
    Review Days
    4

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    Basic Information

    Device Name
    RID PLATES & INTENSI. FOR HUMAN IGE ETC
    K Number
    K771238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    July 11, 1977
    Decision Date
    July 15, 1977
    Product Code
    DGC
    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
    DGC Ige, Antigen, Antiserum, Control

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