---
kind: "section"
citation: "21 C.F.R. § 864.2875"
title: "21"
number: "864.2875"
heading: "Balanced salt solutions or formulations."
url: "https://uscodex.org/cfr/21/864.2875"
---

# §864.2875. Balanced salt solutions or formulations.

- (a) **Identification.** A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.
- (b) **Classification.** Class I (general controls). These devices are exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]

### Authority

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

### Amendments

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]