510(k) K214068 · DGC Ige, Antigen, Antiserum, Control
Quantia IgE
| Applicant | Biokit, S.A., Lliçà D´Amunt, ES |
| Decision | Substantially Equivalent, Feb 21, 2023 |
| Received | Dec 27, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K214068
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.