510(k) DEN240035 · SES Non-Factor Replacement Product Test System
ConcizuTrace ELISA
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Unknown, May 22, 2025 |
| Received | Jul 1, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240035
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.