FDA product code CGC: Radioimmunoassay, Gastrin
CGC is the FDA product code for radioimmunoassay, gastrin. It is a Class I device, regulated under 21 CFR 862.1325 and reviewed by the Clinical Chemistry panel. FDA has cleared 10 510(k) submissions under CGC, from 9 different applicants. The average 510(k) review took 56 days (median 50). FDA has posted 2 recalls for CGC devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Gastrin |
| Device class | Class I |
| Regulation | 21 CFR 862.1325 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CGC clearance
Top CGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno Nuclear Corp. | 2 | 1984-06-26 |
| Biosyn , Ltd. | 1 | 1996-05-30 |
| Syncor Intl. Corp. | 1 | 1984-06-25 |
| Diagnostic Products Corp. | 1 | 1984-01-30 |
| United Diagnostics, Inc. | 1 | 1983-06-22 |
4 more applicants have CGC clearances. See the full list in Caduvo.
Most recent CGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K961276 | Biosyn , Ltd. | GASTRIN EIA MODEL 06B-555017 | 1996-05-30 | 57 |
| K842079 | Immuno Nuclear Corp. | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | 1984-06-26 | 34 |
| K841963 | Syncor Intl. Corp. | GASTRIN RIA | 1984-06-25 | 42 |
| K833489 | Diagnostic Products Corp. | DPC GASTRIN KIT | 1984-01-30 | 115 |
| K831075 | United Diagnostics, Inc. | BLOOD GAS & FLAME PHOTOMETER INSTRU- | 1983-06-22 | 79 |
Recalls for CGC devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-02.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code CGC?
CGC is the FDA product code for radioimmunoassay, gastrin. It is a Class I device, regulated under 21 CFR 862.1325 and reviewed by the Clinical Chemistry panel.
What device class is CGC?
Class I, regulation 21 CFR 862.1325. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CGC?
Across 10 cleared submissions the average was 56 days from receipt to decision (median 50).
Which companies have the most CGC clearances?
Immuno Nuclear Corp. (2); Biosyn , Ltd. (1); Syncor Intl. Corp. (1); Diagnostic Products Corp. (1); United Diagnostics, Inc. (1).
Have CGC devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2018-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code CGC
- Run a recall and safety report across every CGC manufacturer
- Watch product code CGC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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