21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1795

Vanilmandelic acid test system.

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Regulatory Text

21 C.F.R. § 862.1795 — Vanilmandelic acid test system.

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

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21 C.F.R. § 862.1795
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The regulatory text of 21 C.F.R. § 862.1795 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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