21 CFR § 862.1600 - Potassium test system.

---
identifier: "/us/cfr/t21/s862.1600"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1600 - Potassium test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1600"
section_name: "Potassium test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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.