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

    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

    K Number: K000410 · Decision Apr 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    7
    Applicant Total
    270
    Review Days
    62

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
    K Number
    K000410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    February 8, 2000
    Decision Date
    April 10, 2000
    Product Code
    DMT
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DMT Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

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