Radioimmunoassay, Gastrin
The Radioimmunoassay, Gastrin test system (product code CGC) is an in-vitro diagnostic device used in clinical chemistry to quantify gastrin, a gastrointestinal hormone, in serum or plasma using a radioimmunoassay technique. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. It falls under regulation 21 CFR 862.1325 in the Clinical Chemistry medical specialty.
Research product code CGC in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- CGC
- Device Class
- FDA class 1
- Regulation Number
- 862.1325
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961276 | GASTRIN EIA MODEL 06B-555017 | May 30, 1996 | Substantially Equivalent | Biosyn , Ltd. |
| K842079 | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | Jun 26, 1984 | Substantially Equivalent | Immuno Nuclear Corp. |
| K841963 | GASTRIN RIA | Jun 25, 1984 | Substantially Equivalent | Syncor Intl. Corp. |
| K833489 | DPC GASTRIN KIT | Jan 30, 1984 | Substantially Equivalent | Diagnostic Products Corp. |
| K831075 | BLOOD GAS & FLAME PHOTOMETER INSTRU- | Jun 22, 1983 | Substantially Equivalent | United Diagnostics, Inc. |
| K821175 | GASTRIN RADIOIMMUNOASSAY KIT (125-I) | May 14, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K812727 | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | Nov 05, 1981 | Substantially Equivalent | Immuno Nuclear Corp. |
| K812004 | GASTRIN RIA DIAGNOSTIC KIT | Jul 28, 1981 | Substantially Equivalent | Abbott Laboratories |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | May 27, 1981 | Substantially Equivalent | Clinical Assays, Inc. |
| K771953 | GASTRIN RIA MODULE | Jan 20, 1978 | Substantially Equivalent | Inter Science Institute |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.