BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    CYBOW READER, MODELS 300 & 720

    K Number: K102188 · Decision Aug 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    45
    Applicant Total
    4
    Review Days
    371

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    Basic Information

    Device Name
    CYBOW READER, MODELS 300 & 720
    K Number
    K102188
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2900
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DFI Co., Ltd.
    Date Received
    August 3, 2010
    Decision Date
    August 9, 2011
    Product Code
    KQO
    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
    KQO Automated Urinalysis System

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    Other Clearances by DFI Co., Ltd.

    K Number Device Name
    K181024 DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
    K171521 DUS R-50S (Urine Chemistry system)
    K052525 CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS