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For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only.

For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.

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This document is a 510(k) premarket notification acceptance letter from the FDA for medical devices: "Cholesterol Oxidase JAS" and "Glycerol Kinase Triglycerides." This type of document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a summary of safety and effectiveness (SSE). The 510(k) essentially states that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

Therefore, I cannot extract the requested information from the provided text because it is not present in this regulatory acceptance letter. This document is not a study report.

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