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

    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

    K Number: K103230 · Decision Apr 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    540

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    Basic Information

    Device Name
    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
    K Number
    K103230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bestgen Biotech Corp.
    Date Received
    November 1, 2010
    Decision Date
    April 24, 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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    Other Clearances by Bestgen Biotech Corp.

    K Number Device Name
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    K100437 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
    K090389 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
    K072274 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM