---
kind: "section"
citation: "21 C.F.R. § 862.2300"
title: "21"
number: "862.2300"
heading: "Colorimeter, photometer, or spectrophotometer for clinical use."
url: "https://uscodex.org/cfr/21/862.2300"
---

# §862.2300. Colorimeter, photometer, or spectrophotometer for clinical use.

- (a) **Identification.** A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.
- (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]