CGF
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Radioimmunoassay, Estrone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1280
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DSL ESTRONE-SULFATE RIA (K970915) | Diagnostic Systems Laboratories, Inc. | 1997-05-16 |
| DSL ESTRONE (DSL 8700) (K935013) | Diagnostic Systems Laboratories, Inc. | 1994-06-16 |
| ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (K864966) | Diagnostics Biochem Canada, Inc. | 1987-01-09 |
| IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (K833406) | Corning Medical & Scientific | 1984-01-24 |
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Every clearance here is in the API, with alerts when new ones post.