Panels › Clinical Chemistry › Product code CGF · Class 1
Radioimmunoassay, Estrone
Regulation 862.1280
0510(k)s in 12 months (4 all time)
1recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in CGF
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc. | 0 | 2 |
| Diagnostic Systems Laboratories, Inc. | 2 | 0 |
| Immunotech A.S. | 0 | 2 |
| Corning Medical & Scientific | 1 | 0 |
| Diagnostics Biochem Canada, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Immunotech A.S. Estrone RIA, REF: DSL8700 Open, Classified |
CGF | K935013 |
| Aug 18, 2025 | Immunotech A.S. Estrone RIA Catalog Number DSL8700
UDI Code: 15099590211615
Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in Open, Classified |
CGF | K935013 |
| Jul 21, 2025 | Beckman Coulter Inc. Estrone RIA, REF: DSL8700.
Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma. Open, Classified |
CGF | K935013 |
| Mar 17, 2011 | Beckman Coulter Inc. Estrone Radioimmunoassay (RIA) Kit, DSL-8700.
Intended for in vitro diagnostic use. Terminated |
CGF | K935013 |
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