---
kind: "section"
citation: "21 C.F.R. § 862.2400"
title: "21"
number: "862.2400"
heading: "Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use."
url: "https://uscodex.org/cfr/21/862.2400"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000]