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

    URYXXON 200 URINE ANALYZER

    K Number: K051034 · Decision Nov 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    214

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    Basic Information

    Device Name
    URYXXON 200 URINE ANALYZER
    K Number
    K051034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1340
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Macherey-Nagel GmbH & Co. KG
    Date Received
    April 22, 2005
    Decision Date
    November 22, 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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    Other Clearances by Macherey-Nagel GmbH & Co. KG

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    K061742 URYXXON RELAX URINE ANALYZER