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

    IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE

    K Number: K931806 · Decision Jul 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    53
    Applicant Total
    115
    Review Days
    95

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    Basic Information

    Device Name
    IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
    K Number
    K931806
    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
    April 12, 1993
    Decision Date
    July 16, 1993
    Product Code
    CZP
    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
    CZP Iga, Antigen, Antiserum, Control

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