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510(k) Data Aggregation

    K Number
    K061812
    Device Name
    COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
    Manufacturer
    ANALYTICON BIOTECHNOLOGIES AG
    Date Cleared
    2007-04-06

    (284 days)

    Product Code
    JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMA, JMT, KQO, LJX
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALYTICON BIOTECHNOLOGIES AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Combi Scan 500 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
    Device Description
    The Combi Scan 500 is a medium automated urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!
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    K Number
    K061846
    Device Name
    COMBI SCAN100
    Manufacturer
    ANALYTICON BIOTECHNOLOGIES AG
    Date Cleared
    2007-04-06

    (284 days)

    Product Code
    JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMA, JMT, JRE, KQO, LJX
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALYTICON BIOTECHNOLOGIES AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Combi Scan 100 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
    Device Description
    The Combi Scan 100 is a small urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!
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    K Number
    K023885
    Device Name
    COMBI-SCREEN, MODELS 10SL AND 11SL
    Manufacturer
    ANALYTICON BIOTECHNOLOGIES AG
    Date Cleared
    2003-10-21

    (334 days)

    Product Code
    JIL, JIN, JJB, JMA, JMT
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANALYTICON BIOTECHNOLOGIES AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine.
    Device Description
    The urine test strips can be used for the determination of the complete chemical urine status with the parameters: bilirubin, blood, ketones, glucose, leukocytes, nitrite, pH-value, protein, urobilinogen. In addition the specific gravity can be tested. With it early symptoms of three great groups of diseases can be indicated: Disorders of the carbohydrate metabolism (diabetes) Illness of the kidney and urinary passages (e.g. infections of urinary passages, tumors, glomerulonephritis, pyelonephritis) Illness of liver and haemolytic disorders.
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