CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES > SUBPART C—Clinical Laboratory Instruments (§862.2050 to §862.2920) > 862.2230—Chromatographic separation material for clinical use.

862.2230—Chromatographic separation material for clinical use.

(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.

Code of Federal Regulations

[52 FR 16122, May 1, 1987, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38788, July 25, 2001]