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

    DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)

    K Number: K801300 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    16
    Applicant Total
    253
    Review Days
    36

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    Basic Information

    Device Name
    DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
    K Number
    K801300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    June 2, 1980
    Decision Date
    July 8, 1980
    Product Code
    JIW
    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
    JIW Calibrator, Surrogate

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