21 CFR 862.1780

§ 862.1780 Urinary calculi (stones) test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.1780, § 862.1780 Urinary calculi (stones) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89199
Permanent ID: ys:prov:89199@1
SHA-256: 1d99986ef4ea879f6eb46a33a7788317f0fa0a88772369a0b864081441f61aae

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Full text

(a) Identification. A urinary calculi (stones) test system is a device intended for the analysis of urinary calculi. Analysis of urinary calculi is used in the diagnosis and treatment of calculi of the urinary tract. (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.