21 CFR 864.2875
§ 864.2875 Balanced salt solutions or formulations.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.2875, § 864.2875 Balanced salt solutions or formulations, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89315
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Full text
(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 of this chapter subject to the limitations in § 864.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.