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

    TRUQUANT BR RIA

    K Number: K965141 · Decision Oct 31, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    312

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    Basic Information

    Device Name
    TRUQUANT BR RIA
    K Number
    K965141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomira USA, Inc.
    Date Received
    December 23, 1996
    Decision Date
    October 31, 1997
    Product Code
    MOI
    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
    MOI System, Test, Immunological, Antigen, Tumor

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