21 CFR 862.2540
§ 862.2540 Flame emission photometer for clinical use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.2540, § 862.2540 Flame emission photometer for clinical use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89228
- Permanent ID
ys:prov:89228@1- SHA-256
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Full text
(a) Identification. A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) and are, therefore, useful in diagnosis and treatment of those disorders.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.