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

    REFLOTRON BILIRUBIN

    K Number: K872818 · Decision Nov 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    340
    Review Days
    130

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    Basic Information

    Device Name
    REFLOTRON BILIRUBIN
    K Number
    K872818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    July 16, 1987
    Decision Date
    November 23, 1987
    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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