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

    ACCU-CHEK AVIVA EXPERT SYSTEM

    K Number: K142089 · Decision Dec 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    68
    Same Product Code
    72
    Applicant Total
    6
    Review Days
    138

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    Basic Information

    Device Name
    ACCU-CHEK AVIVA EXPERT SYSTEM
    K Number
    K142089
    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 Corporation
    Date Received
    August 1, 2014
    Decision Date
    December 17, 2014
    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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    K Number Device Name
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    K070172 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
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