Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1325](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1325) → CGC — Radioimmunoassay, Gastrin

# CGC · Radioimmunoassay, Gastrin

_Clinical Chemistry · 21 CFR 862.1325 · Class 1_

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

## Overview

- **Product Code:** CGC
- **Device Name:** Radioimmunoassay, Gastrin
- **Regulation:** [21 CFR 862.1325](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1325)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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).

## 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 § 862.9.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K961276](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K961276.md) | GASTRIN EIA MODEL 06B-555017 | Biosyn , Ltd. | May 30, 1996 | SESE |
| [K842079](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K842079.md) | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | Immuno Nuclear Corp. | Jun 26, 1984 | SESE |
| [K841963](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K841963.md) | GASTRIN RIA | Syncor Intl. Corp. | Jun 25, 1984 | SESE |
| [K833489](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K833489.md) | DPC GASTRIN KIT | Diagnostic Products Corp. | Jan 30, 1984 | SESE |
| [K831075](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K831075.md) | BLOOD GAS & FLAME PHOTOMETER INSTRU- | United Diagnostics, Inc. | Jun 22, 1983 | SESE |
| [K821175](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K821175.md) | GASTRIN RADIOIMMUNOASSAY KIT (125-I) | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 14, 1982 | SESE |
| [K812727](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K812727.md) | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | Nov 5, 1981 | SESE |
| [K812004](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K812004.md) | GASTRIN RIA DIAGNOSTIC KIT | Abbott Laboratories | Jul 28, 1981 | SESE |
| [K810722](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K810722.md) | GASTRIN RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | May 27, 1981 | SESE |
| [K771953](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGC/K771953.md) | GASTRIN RIA MODULE | Inter Science Institute | Jan 20, 1978 | SESE |

## Top Applicants

- Immuno Nuclear Corp. — 2 clearances
- Abbott Laboratories — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biosyn , Ltd. — 1 clearance
- Clinical Assays, Inc. — 1 clearance

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

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