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

    TOTAL & DIRECT BILIRUBIN PROCEDURES

    K Number: K832942 · Decision Nov 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    23
    Review Days
    69

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    Basic Information

    Device Name
    TOTAL & DIRECT BILIRUBIN PROCEDURES
    K Number
    K832942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sandare Chemical Co., Inc.
    Date Received
    August 30, 1983
    Decision Date
    November 7, 1983
    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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