§ 862.2400. Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
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/us/cfr/t21/s§ 862.2400·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.
(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]