510(k) K211058 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Lp(a) Ultra
| Applicant | SENTINEL CH. SpA, Milan, IT |
| Decision | Substantially Equivalent, Dec 22, 2022 |
| Received | Apr 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211058
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.