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

    ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM

    K Number: K131366 · Decision Oct 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    68
    Same Product Code
    72
    Applicant Total
    2
    Review Days
    151

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    Basic Information

    Device Name
    ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
    K Number
    K131366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations, Inc.
    Date Received
    May 13, 2013
    Decision Date
    October 11, 2013
    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 Roche Diagnostics Operations, Inc.

    K Number Device Name
    K131029 ACCU-CHEK AVIVA PLUS TEST STRIP