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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1600

§ 862.1600. Potassium test system.

49 words·~1 min read·/us/cfr/t21/s§ 862.1600·

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(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.
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