510(k) K210801 · MRR System, Test, Low Density, Lipoprotein
AXINON® LDL-p Test System
| Applicant | Numares AG, Regensburg, DE |
| Decision | Substantially Equivalent, Jul 19, 2023 |
| Received | Mar 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210801
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.