BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K063212 · Decision Nov 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    178
    Same Product Code
    506
    Applicant Total
    118
    Review Days
    30

    Basic Information

    Device Name
    CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K063212
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TaiDoc Technology Corporation
    Date Received
    October 23, 2006
    Decision Date
    November 22, 2006
    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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