510(k) K250588 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Access Rubella IgG
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Nov 17, 2025 |
| Received | Feb 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250588
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.