510(k) K241534 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
VITROS Immunodiagnostic Products Syphilis Reagent Pack
| Applicant | Ortho Clinical Diagnostics, Bridgend, GB |
| Decision | Substantially Equivalent, Aug 28, 2024 |
| Received | May 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241534
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.