← Product Code [CGC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC) · K810722

# GASTRIN RADIOIMMUNOASSAY TEST (K810722)

_Clinical Assays, Inc. · CGC · May 27, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K810722

## Device Facts

- **Applicant:** Clinical Assays, Inc.
- **Product Code:** [CGC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC.md)
- **Decision Date:** May 27, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1325
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K810722](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K810722)

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