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

    URISCAN OPTIMA II URINE ANALYZER

    K Number: K050801 · Decision Apr 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    21

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    Basic Information

    Device Name
    URISCAN OPTIMA II URINE ANALYZER
    K Number
    K050801
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Yd Diagnostics
    Date Received
    March 30, 2005
    Decision Date
    April 20, 2005
    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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