21 C.F.R. § 862.2250 Gas liquid chromatography system for clinical use.
Title 21 - Food and Drugs
(a) Identification. A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating. (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 2309, Jan. 14, 2000]
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments
§ 862.2250 Gas liquid chromatography system for clinical use.
