BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10

    K Number: K060359 · Decision Apr 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    6
    Review Days
    60

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    Basic Information

    Device Name
    ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
    K Number
    K060359
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denka Seiken Co., Ltd.
    Date Received
    February 13, 2006
    Decision Date
    April 14, 2006
    Product Code
    JIT
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JIT Calibrator, Secondary

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