§ 862.1345. Glucose test system.
113 words·~1 min read·
/us/cfr/t21/s§ 862.1345·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
(b)Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020]
Connections1 cite this
Cited by 1 section
Citation graph
cites case law
§ 862.1345
Glucose test system.
Fed. Reg.×1
Cites 0Cited by 1 across 1 source