JLL · Tubeless Analysis, Gastric Acidity
Clinical Chemistry · 21 CFR 862.1320 · Class 1
Overview
| Product Code | JLL |
|---|---|
| Device Name | Tubeless Analysis, Gastric Acidity |
| Regulation | 21 CFR 862.1320 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 Rationale
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.
Cleared Devices (0)
No cleared devices on record.
