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

    ARCHITECT TACROLIMUS: MODEL 1L77

    K Number: K070820 · Decision Aug 1, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    45
    Review Days
    128

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    Basic Information

    Device Name
    ARCHITECT TACROLIMUS: MODEL 1L77
    K Number
    K070820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1678
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    March 26, 2007
    Decision Date
    August 1, 2007
    Product Code
    MLM
    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
    MLM Enzyme Immunoassay, Tracrolimus

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