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

    TRILOGY ANALYZER

    K Number: K070704 · Decision Jul 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    2
    Review Days
    122

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    Basic Information

    Device Name
    TRILOGY ANALYZER
    K Number
    K070704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drew Scientific, Inc.
    Date Received
    March 13, 2007
    Decision Date
    July 13, 2007
    Product Code
    CGA
    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
    CGA Glucose Oxidase, Glucose

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    Other Clearances by Drew Scientific, Inc.

    K Number Device Name
    K071562 D3 HEMATOLOGY ANALYZER, MODEL D3