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

    I-L TEST, DIRECT BILIRUBIN SET

    K Number: K850748 · Decision Apr 3, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    7
    Review Days
    37

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    Basic Information

    Device Name
    I-L TEST, DIRECT BILIRUBIN SET
    K Number
    K850748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Allied Instrumentation Laboratory
    Date Received
    February 25, 1985
    Decision Date
    April 3, 1985
    Product Code
    CIG
    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
    CIG Diazo Colorimetry, Bilirubin

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