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

    EN TYPING CIE KIT FOR DIAGNOSTIC USE

    K Number: K925118 · Decision Feb 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    115
    Review Days
    162

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    Basic Information

    Device Name
    EN TYPING CIE KIT FOR DIAGNOSTIC USE
    K Number
    K925118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    August 24, 1992
    Decision Date
    February 2, 1993
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

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