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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter HPart 862Subpart C → §862.2230


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments


§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.

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

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