§ 862.1815. Vitamin E test system.
86 words·~1 min read·
/us/cfr/t21/s§ 862.1815·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A vitamin E test system is a device intended to measure vitamin E (tocopherol) in serum. Measurements obtained by this device are used in the diagnosis and treatment of infants with vitamin E deficiency syndrome.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001]