510(k) K252728 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
IDS-iSYS Total Testosterone
| Applicant | Immunodiagnostic Systems Limited, Tyne & Wear, GB |
| Decision | Substantially Equivalent, Apr 15, 2026 |
| Received | Aug 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252728
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.