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

    TINA-QUANT CERULOPLASMIN

    K Number: K091741 · Decision Mar 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    183
    Review Days
    275

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    Basic Information

    Device Name
    TINA-QUANT CERULOPLASMIN
    K Number
    K091741
    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
    Date Received
    June 16, 2009
    Decision Date
    March 18, 2010
    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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