510(k) K190851 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
HYDRASHIFT 2/4 daratumumab
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, May 2, 2019 |
| Received | Apr 2, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190851
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.