§ 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.