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510(k) Data Aggregation

    K Number
    K991720
    Device Name
    KRONUS OPTIQUANT THYROGLOBULIN KIT
    Manufacturer
    Date Cleared
    1999-08-09

    (81 days)

    Product Code
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNCHANGED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    is intended for the quantitative determination of thyroglobulin (Tg) in human serum as an aid in the detection of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioiodine), and who lack serum thyroglobulin antibodies.
    Device Description
    Not Found
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