21 CFR 864.2875 — Formulations, Balanced Salt Solutions
Hematology (HE) · Part 864 Subpart C—Cell And Tissue Culture Products · § 864.2875
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | 1 | 17 |
