21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(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 .
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Federal Register documents that created or amended this section.