510(k) K241427 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Access Syphilis
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 6, 2024 |
| Received | May 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241427
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.