21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1780

Urinary calculi (stones) test system.

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21 C.F.R. § 862.1780 — Urinary calculi (stones) test system.

§ 862.1780 Urinary calculi (stones) test system. (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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

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21 C.F.R. § 862.1780
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The regulatory text of 21 C.F.R. § 862.1780 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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