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

    SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K100398 · Decision Jun 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    3
    Review Days
    113

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    Basic Information

    Device Name
    SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K100398
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Diagnostics, Inc.
    Date Received
    February 16, 2010
    Decision Date
    June 9, 2010
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Standard Diagnostics, Inc.

    K Number Device Name
    K082683 SD CHECK GOLD
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