CGC — Radioimmunoassay, Gastrin Class I
FDA product code CGC covers "Radioimmunoassay, Gastrin", a Class I medical device regulated under 21 CFR 862.1325. Submissions are reviewed by the Clinical Chemistry panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGC
- Device Class
- Class I
- Regulation Number
- 862.1325
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K961276 | biosyn | GASTRIN EIA MODEL 06B-555017 | May 30, 1996 |
| K842079 | immuno nuclear | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | June 26, 1984 |
| K841963 | syncor intl | GASTRIN RIA | June 25, 1984 |
| K833489 | diagnostic products | DPC GASTRIN KIT | January 30, 1984 |
| K831075 | united diagnostics | BLOOD GAS & FLAME PHOTOMETER INSTRU- | June 22, 1983 |
| K821175 | bd becton dickinson vacutainer systems preanalytic | GASTRIN RADIOIMMUNOASSAY KIT (125-I) | May 14, 1982 |
| K812727 | immuno nuclear | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | November 5, 1981 |
| K812004 | abbott laboratories | GASTRIN RIA DIAGNOSTIC KIT | July 28, 1981 |
| K810722 | clinical assays | GASTRIN RADIOIMMUNOASSAY TEST | May 27, 1981 |
| K771953 | inter science institute | GASTRIN RIA MODULE | January 20, 1978 |