BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMS GLUCOSE CONTROL, MODEL 2120059

    K Number: K071433 · Decision Jun 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    1
    Review Days
    36

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    Basic Information

    Device Name
    SMS GLUCOSE CONTROL, MODEL 2120059
    K Number
    K071433
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Specialty Medical Supplies
    Date Received
    May 23, 2007
    Decision Date
    June 28, 2007
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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