21 C.F.R. § 862.2250

Current through September 30, 2024
Section 862.2250 - Gas liquid chromatography system for clinical use
(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 .

21 C.F.R. §862.2250

52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000