21 CFR 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 of this chapter subject to the limitations in § 864.9.