BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇹 Italy

    SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

    K Number: K051114 · Decision Nov 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    29
    Applicant Total
    10
    Review Days
    207

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    Basic Information

    Device Name
    SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
    K Number
    K051114
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1065
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentinel Ch. Srl
    Date Received
    May 2, 2005
    Decision Date
    November 25, 2005
    Product Code
    JIF
    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
    JIF Enzymatic Method, Ammonia

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