21 CFR § 862.1600 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1600 Potassium test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) 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.

(b) Classification. Class II.

← § 862.1595 Porphyrins test system.§ 862.1602 Prognostic test for development or progression of preeclampsia. →