510(k) K935013 ยท CGF Radioimmunoassay, Estrone
DSL ESTRONE (DSL 8700)
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Jun 16, 1994 |
| Received | Oct 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935013
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Immunotech A.S. Estrone RIA, REF: DSL8700 Open, Classified |
CGF | None listed |
| 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 | None listed |
| 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 | None listed |
| Mar 17, 2011 | Beckman Coulter Inc. Estrone Radioimmunoassay (RIA) Kit, DSL-8700.
Intended for in vitro diagnostic use. Terminated |
CGF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.