§862.1320. Gastric acidity test system.
21 C.F.R. § 862.1320
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001]