Electronic Code of Federal Regulations
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e-CFR data is current as of March 3, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart C → §862.2400 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments
§862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
(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]