21 CFR 862.1320
§ 862.1320 Gastric acidity test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1320, § 862.1320 Gastric acidity test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89104
- Permanent ID
ys:prov:89104@1- SHA-256
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Full text
(a) Identification. A gastric acidity test system is a device intended to measure the acidity of gastric fluid. Measurements of gastric acidity are used in the diagnosis and treatment of patients with peptic ulcer, Zollinger-Ellison syndrome (peptic ulcer due to gastrin-secreting tumor of the pancreas), and related gastric disorders.
(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 the limitations in § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.