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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR862.1795]
See Related Information on Vanilmandelic acid test system. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart B--Clinical Chemistry Test Systems

Sec. 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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