§ 862.1080. Androsterone test system.
77 words·~1 min read·
/us/cfr/t21/s§ 862.1080·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.
(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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]