BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023

    K Number: K082275 · Decision Jan 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    20
    Review Days
    521

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    Basic Information

    Device Name
    CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
    K Number
    K082275
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infopia Co, Ltd.
    Date Received
    August 11, 2008
    Decision Date
    January 14, 2010
    Product Code
    LCP
    Advisory Committee
    Hematology
    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
    LCP Assay, Glycosylated Hemoglobin

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