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

    SENOVA(R) BLOOD GLUCOSE MONITOR

    K Number: K032076 · Decision Sep 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    67
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    85

    Basic Information

    Device Name
    SENOVA(R) BLOOD GLUCOSE MONITOR
    K Number
    K032076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CHDIAGNOSTICS LLC
    Date Received
    July 7, 2003
    Decision Date
    September 30, 2003
    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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