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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    DUS R-50S (Urine Chemistry system)

    K Number: K171521 · Decision Feb 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    4
    Review Days
    268

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    Basic Information

    Device Name
    DUS R-50S (Urine Chemistry system)
    K Number
    K171521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DFI Co., Ltd.
    Date Received
    May 24, 2017
    Decision Date
    February 16, 2018
    Product Code
    JIL
    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
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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    Other Clearances by DFI Co., Ltd.

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    K102188 CYBOW READER, MODELS 300 & 720
    K052525 CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS