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

    URISCAN OPTIMA

    K Number: K141874 · Decision May 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    321

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    Basic Information

    Device Name
    URISCAN OPTIMA
    K Number
    K141874
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2900
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yd Diagnostics Corp.
    Date Received
    July 11, 2014
    Decision Date
    May 28, 2015
    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 Yd Diagnostics Corp.

    K Number Device Name
    K060953 OCCULTECH FECAL OCCULT BLOOD RAPID TEST