510(k) K231601 ยท DFH Kappa, Antigen, Antiserum, Control
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Feb 23, 2024 |
| Received | Jun 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231601
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.