BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNCHRON SYSTEMS AMMONIA REAGENT

    K Number: K003196 · Decision Dec 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    29
    Applicant Total
    270
    Review Days
    71

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS AMMONIA REAGENT
    K Number
    K003196
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1065
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    October 12, 2000
    Decision Date
    December 22, 2000
    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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