BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MICRODOT & MICRODOT XTRA

    K Number: K102383 · Decision Jan 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    3
    Review Days
    522

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    Basic Information

    Device Name
    MICRODOT & MICRODOT XTRA
    K Number
    K102383
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cambridge Sensors Limited
    Date Received
    August 23, 2010
    Decision Date
    January 27, 2012
    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 Cambridge Sensors Limited

    K Number Device Name
    K083273 MICRODOT XTRA
    K070524 MICRODOT BLOOD GLUCOSE MONITORING SYSTEM