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

    GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM

    K Number: K113307 · Decision Jul 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    67
    Same Product Code
    72
    Applicant Total
    8
    Review Days
    262

    Basic Information

    Device Name
    GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
    K Number
    K113307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HMD BIOMEDICAL, INC.
    Date Received
    November 8, 2011
    Decision Date
    July 27, 2012
    Product Code
    LFR
    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
    LFR Glucose Dehydrogenase, Glucose

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    Other Clearances by HMD BIOMEDICAL, INC.

    K Number Device Name
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