21 CFR 862.1600 — Tetraphenyl Borate, Colorimetry, Potassium
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1600
Identification
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 2 | 16 | 3rd Party |
| CEM | Electrode, Ion Specific, Potassium | 2 | 89 | 3rd Party |
| JGM | Flame Photometry, Potassium | 2 | 5 | 3rd Party |
| MZV | Test, System, Potassium, Enzymatic Method | 2 | 4 | 3rd Party |
