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

    S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)

    K Number: K140248 · Decision Mar 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    85
    Applicant Total
    16
    Review Days
    40

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    Basic Information

    Device Name
    S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
    K Number
    K140248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Chemical Diagnostics, Inc.
    Date Received
    January 30, 2014
    Decision Date
    March 11, 2014
    Product Code
    KHS
    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
    KHS Enzymatic, Carbon-Dioxide

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