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510(k) Data Aggregation

    K Number
    K062503
    Device Name
    CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
    Manufacturer
    CATACHEM, INC.
    Date Cleared
    2007-01-19

    (147 days)

    Product Code
    KWWJISJJX
    Regulation Number
    862.1177
    Why did this record match?
    Applicant Name (Manufacturer) :

    CATACHEM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Catachem, Inc. Bile Acids assay is an In-Vitro diagnostic enzymatic assay for the quantitative determination of total bile acids in human serum. Measurement of bile acids in human serum, and increased reported levels are representative of specific liver disease. For In-Vitro diagnostic use only Bile Acids Calibrator. (For In-Vitro diagnostic use only) The bile acids assay contains a calibrator designed for the calibration of the Bile Acids method. Bile Acids Controls (For In-Vitro diagnostic use only) The bile acids assay also contains control Level-I and control Level-II. These controls are designed to monitor the performance of the Bile Acids assay.
    Device Description
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