21 C.F.R. § 862.1805

Current through September 30, 2024
Section 862.1805 - Vitamin A test system
(a)Identification. A vitamin A test system is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestinal disorders.
(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. §862.1805

52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000