FDA product code CGF: Radioimmunoassay, Estrone
CGF is the FDA product code for radioimmunoassay, estrone. It is a Class I device, regulated under 21 CFR 862.1280 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under CGF, from 3 different applicants. The average 510(k) review took 110 days (median 90). FDA has posted 4 recalls for CGF devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Estrone |
| Device class | Class I |
| Regulation | 21 CFR 862.1280 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CGF clearance
Top CGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 2 | 1997-05-16 |
| Diagnostics Biochem Canada, Inc. | 1 | 1987-01-09 |
| Corning Medical & Scientific | 1 | 1984-01-24 |
Most recent CGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970915 | Diagnostic Systems Laboratories, Inc. | DSL ESTRONE-SULFATE RIA | 1997-05-16 | 65 |
| K935013 | Diagnostic Systems Laboratories, Inc. | DSL ESTRONE (DSL 8700) | 1994-06-16 | 239 |
| K864966 | Diagnostics Biochem Canada, Inc. | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | 1987-01-09 | 18 |
| K833406 | Corning Medical & Scientific | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY | 1984-01-24 | 116 |
Recalls for CGF devices
4 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-12-15.
| Year | Recalls |
|---|---|
| 2025 | 3 |
Frequently asked questions
What is FDA product code CGF?
CGF is the FDA product code for radioimmunoassay, estrone. It is a Class I device, regulated under 21 CFR 862.1280 and reviewed by the Clinical Chemistry panel.
What device class is CGF?
Class I, regulation 21 CFR 862.1280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CGF?
Across 4 cleared submissions the average was 110 days from receipt to decision (median 90).
Which companies have the most CGF clearances?
Diagnostic Systems Laboratories, Inc. (2); Diagnostics Biochem Canada, Inc. (1); Corning Medical & Scientific (1).
Have CGF devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2025-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code CGF
- Run a recall and safety report across every CGF manufacturer
- Watch product code CGF 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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