21 C.F.R. § 862.1795

Current through October 31, 2024
Section 862.1795 - Vanilmandelic acid test system
(a)Identification. A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.
(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 .

21 C.F.R. §862.1795

52 FR 16122, May 1, 1987, as amended at 65 FR 2308 , Jan. 14, 2000