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510(k) Data Aggregation

    K Number
    K061742
    Device Name
    URYXXON RELAX URINE ANALYZER
    Date Cleared
    2006-09-06

    (78 days)

    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MACHEREY-NAGEL GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The URYXXON® Relax is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes metabolic abnormalities, liver diseases, biliary and hepatic obstructions of the kidneys and urinary tract. The test provided on MACHEREY-NAGEL Reagent strips for the determination of specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis.
    Device Description
    Not Found
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    K Number
    K051034
    Device Name
    URYXXON 200 URINE ANALYZER
    Date Cleared
    2005-11-22

    (214 days)

    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    **MACHEREY-NAGEL GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The URYXXON® 200 is a portable reflectance photometer that instrumentally measures the reflectance on a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The product is intended for use on urine specimens for the semi-quantitative determination of blood, urobilinogen, bilirubin, protein, nitrite, ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes. The test results are used in the evaluation of diabetes, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract. The test provided on Macherey-Nagel Reagent Strips for the determination of specific gravity, leucocytes, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis.
    Device Description
    The URYXXON® 200 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative reading of Medi-Test Combi 11 urine test strips for the following analytes: blood, urobilinogen, bilirubin, protein, nitrite, ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes.
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