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Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1095 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1095 Ascorbic acid test system.
(a) Identification. An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.
(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 2305, Jan. 14, 2000]