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

    FORA V10 BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K121706 · Decision Jan 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    5
    Review Days
    220

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    Basic Information

    Device Name
    FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K121706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foracare, Inc.
    Date Received
    June 8, 2012
    Decision Date
    January 14, 2013
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

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