Radioimmunoassay, Estrone
FDA product code CGF · Class I (low risk) · 21 CFR 862.1280 · Clinical Chemistry
4510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970915 | DSL Estrone-Sulfate RiaCGF · Traditional | Diagnostic Systems Laboratories, Inc. | 05/16/1997SE |
| K935013 | DSL Estrone (DSL 8700)CGF · Traditional | Diagnostic Systems Laboratories, Inc. | 06/16/1994SE |
| K864966 | Estrone Analysis Products Radioimmunoassay EstroneCGF · Traditional | Diagnostics Biochem Canada, Inc. | 01/09/1987SE |
| K833406 | Immophase D-Te 3 RadioimmunoassayCGF · Traditional | Corning Medical & Scientific | 01/24/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1369-2026 Class II | Estrone RIA, REF: DSL8700The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary… | Immunotech A.S. | 12/15/2025Open, Classified |
| Z-2336-2025 Class II | Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro…Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of… | Immunotech A.S. | 06/12/2025Open, Classified |
| Z-2152-2025 Class II | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement…A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included… | Beckman Coulter Inc. | 06/12/2025Open, Classified |
| Z-1685-2011 | Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.Beckman Coulter has confirmed that eight Estrone RIA kit (Ref DSL 8700) lots are inaccurately calibrated to… | Beckman Coulter Inc. | 04/22/2010Terminated |