510(k) K251105 ยท PKP Immunoglobulin G (Igg) Infusion System
Tetra (TM-20); Tetra (TM-50)
| Applicant | Emed Technologies Corporation, El Dorado Hills CA, US |
| Decision | Substantially Equivalent, Dec 22, 2025 |
| Received | Apr 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251105
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.