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510(k) Data Aggregation
K Number
K991720Device Name
KRONUS OPTIQUANT THYROGLOBULIN KIT
Manufacturer
Date Cleared
1999-08-09
(81 days)
Product Code
Regulation Number
866.6010Why 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
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