(a)Identification. A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.
(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 the limitations in 862.9.
[52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38788, July 25, 2001]