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

    AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K103116 · Decision Mar 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    509

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    Basic Information

    Device Name
    AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K103116
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bestgen Biotech Corp.
    Date Received
    October 21, 2010
    Decision Date
    March 13, 2012
    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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