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

    TOTAL BILIRUBIN PROCEDURE

    K Number: K861651 · Decision May 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    233
    Applicant Total
    111
    Review Days
    29

    Basic Information

    Device Name
    TOTAL BILIRUBIN PROCEDURE
    K Number
    K861651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    DATA MEDICAL ASSOCIATES, INC.
    Date Received
    April 30, 1986
    Decision Date
    May 29, 1986
    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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