21 CFR § 862.2250 Clinical Chemistry and Clinical Toxicology Devices

§ 862.2250 Gas liquid chromatography system for clinical use.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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]

← § 862.2230 Chromatographic separation material for clinical use.§ 862.2260 High pressure liquid chromatography system for clinical use. →