21 C.F.R. § 862.1600

Current through November 30, 2024
Section 862.1600 - Potassium test system
(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.

21 C.F.R. § 862.1600