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

    LYPHOCHEK DIABETES CONTROL

    K Number: K070546 · Decision Apr 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    14
    Applicant Total
    46
    Review Days
    35

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    Basic Information

    Device Name
    LYPHOCHEK DIABETES CONTROL
    K Number
    K070546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories
    Date Received
    February 26, 2007
    Decision Date
    April 2, 2007
    Product Code
    GGM
    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
    GGM Control, Hemoglobin

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