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

    ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)

    K Number: K170065 · Decision Mar 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    152
    Review Days
    59

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    Basic Information

    Device Name
    ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
    K Number
    K170065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    January 9, 2017
    Decision Date
    March 9, 2017
    Product Code
    JFM
    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
    JFM Enzymatic Method, Bilirubin

    Similar 510(k) Clearances

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    WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

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    DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR

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