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

    CERULOPLASMIN, MODEL 2055953

    K Number: K062114 · Decision Jan 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    264
    Review Days
    191

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    Basic Information

    Device Name
    CERULOPLASMIN, MODEL 2055953
    K Number
    K062114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    July 24, 2006
    Decision Date
    January 31, 2007
    Product Code
    CHN
    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
    CHN Immunochemical, Ceruloplasmin

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