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

    IGE EIA TEST KIT

    K Number: K920087 · Decision Sep 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    115
    Review Days
    250

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    Basic Information

    Device Name
    IGE EIA TEST KIT
    K Number
    K920087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    January 8, 1992
    Decision Date
    September 14, 1992
    Product Code
    DGO
    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
    DGO Ige, Peroxidase, Antigen, Antiserum, Control

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