510(k) K172195 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
HYDRASHIFT 2/4 daratumumab, daratumumab Control
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Jan 11, 2018 |
| Received | Jul 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172195
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.