21 C.F.R. § 862.2260 High pressure liquid chromatography system for clinical use.
Title 21 - Food and Drugs
(a) Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity. (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
§ 862.2260 High pressure liquid chromatography system for clinical use.
