21 CFR 862.1600
§ 862.1600 Potassium test system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 862.1600, § 862.1600 Potassium test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89166
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.