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

    ARCHITECT CYCLOSPORINE

    K Number: K080751 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    8
    Applicant Total
    45
    Review Days
    177

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    Basic Information

    Device Name
    ARCHITECT CYCLOSPORINE
    K Number
    K080751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    March 18, 2008
    Decision Date
    September 11, 2008
    Product Code
    MKW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKW Cyclosporine

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