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

    S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN

    K Number: K131217 · Decision Jun 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    16
    Review Days
    38

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    Basic Information

    Device Name
    S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
    K Number
    K131217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Chemical Diagnostics, Inc.
    Date Received
    April 30, 2013
    Decision Date
    June 7, 2013
    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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