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510(k) Data Aggregation

    K Number
    K972706
    Device Name
    CLINITEK MICROALBUMIN REAGENT STRIPS
    Manufacturer
    BAYER CORP.
    Date Cleared
    1997-09-09

    (50 days)

    Product Code
    CJG, JFY
    Regulation Number
    862.1035
    Why did this record match?
    Product Code :

    CJG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLINITEK Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria) creatinine) in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use.
    Device Description
    CLINITEK® Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. CLINITEK Microalbumin Reagent Strips are dipped into a urine specimen and "read" instrumentally by the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio is also determined. Semi-quantitative results are available within one minute.
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