21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1710

Total triiodothyronine test system.

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21 C.F.R. § 862.1710 — Total triiodothyronine test system.

§ 862.1710 Total triiodothyronine test system. (a) Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. (b) Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 62286, Oct. 18, 2000]

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21 C.F.R. § 862.1710
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The regulatory text of 21 C.F.R. § 862.1710 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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