CGC · Radioimmunoassay, Gastrin
Clinical Chemistry · 21 CFR 862.1325 · Class 1
Overview
| Product Code | CGC |
|---|---|
| Device Name | Radioimmunoassay, Gastrin |
| Regulation | 21 CFR 862.1325 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961276 | GASTRIN EIA MODEL 06B-555017 | Biosyn , Ltd. | May 30, 1996 | SESE |
| K842079 | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | Immuno Nuclear Corp. | Jun 26, 1984 | SESE |
| K841963 | GASTRIN RIA | Syncor Intl. Corp. | Jun 25, 1984 | SESE |
| K833489 | DPC GASTRIN KIT | Diagnostic Products Corp. | Jan 30, 1984 | SESE |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | United Diagnostics, Inc. | Jun 22, 1983 | SESE |
| K821175 | GASTRIN RADIOIMMUNOASSAY KIT (125-I) | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 14, 1982 | SESE |
| K812727 | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | Nov 5, 1981 | SESE |
| K812004 | GASTRIN RIA DIAGNOSTIC KIT | Abbott Laboratories | Jul 28, 1981 | SESE |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | May 27, 1981 | SESE |
| K771953 | GASTRIN RIA MODULE | Inter Science Institute | Jan 20, 1978 | SESE |
Top Applicants
- Immuno Nuclear Corp. — 2 clearances
- United Diagnostics, Inc. — 1 clearance
- Syncor Intl. Corp. — 1 clearance
- Inter Science Institute — 1 clearance
- Diagnostic Products Corp. — 1 clearance
