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

    RIT LIVER, KIDNEY, STOMACH IFA KIT

    K Number: K955431 · Decision Apr 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    115
    Review Days
    147

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    Basic Information

    Device Name
    RIT LIVER, KIDNEY, STOMACH IFA KIT
    K Number
    K955431
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    November 28, 1995
    Decision Date
    April 23, 1996
    Product Code
    DBL
    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
    DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

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