510(k) K203184 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
HYDRASHIFT 2/4 isatuximab
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Nov 12, 2021 |
| Received | Oct 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203184
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.