(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 Sec. 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]