BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

    K Number: K082210 · Decision Dec 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
    K Number
    K082210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genzyme Diagnostics P.E.I., Inc.
    Date Received
    August 6, 2008
    Decision Date
    December 16, 2008
    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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    Other Clearances by Genzyme Diagnostics P.E.I., Inc.

    K Number Device Name
    K081938 ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30