21 C.F.R. § 862.1430

Current through October 31, 2024
Section 862.1430 - 17-Ketosteroids test system
(a)Identification. A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .

21 C.F.R. §862.1430

52 FR 16122, May 1, 1987, as amended at 65 FR 2307 , Jan. 14, 2000