21 CFR 862.1430
§ 862.1430 17-Ketosteroids test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1430, § 862.1430 17-Ketosteroids test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89129
- Permanent ID
ys:prov:89129@1- SHA-256
9012acd6d2489a0a454e1a4dec3fa18b5874332cd19e64209e24d1200efaa230
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Full text
(a) Identification. A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.
(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.