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510(k) Data Aggregation

    K Number
    K980525
    Device Name
    UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
    Manufacturer
    MARUKIN SHOYU CO., LTD.
    Date Cleared
    1998-04-15

    (63 days)

    Product Code
    KWX
    Regulation Number
    862.1187
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARUKIN SHOYU CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Marukin Shoyu Co., Ltd's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.
    Device Description
    Assay Kits for Urinary Total Bile Acid Sulfate
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