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

    S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE

    K Number: K132462 · Decision Oct 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    16
    Review Days
    82

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    Basic Information

    Device Name
    S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
    K Number
    K132462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Chemical Diagnostics, Inc.
    Date Received
    August 7, 2013
    Decision Date
    October 28, 2013
    Product Code
    CDN
    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
    CDN Urease, Photometric, Urea Nitrogen

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