CGF — Radioimmunoassay, Estrone Class I
FDA product code CGF covers "Radioimmunoassay, Estrone", a Class I medical device regulated under 21 CFR 862.1280. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGF
- Device Class
- Class I
- Regulation Number
- 862.1280
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970915 | diagnostic systems laboratories | DSL ESTRONE-SULFATE RIA | May 16, 1997 |
| K935013 | diagnostic systems laboratories | DSL ESTRONE (DSL 8700) | June 16, 1994 |
| K864966 | diagnostics biochem canada | ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE | January 9, 1987 |
| K833406 | corning medical and scientific | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY | January 24, 1984 |