510(k) K153145 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Lumipulse G TP-N Immunoreaction Cartridge Set
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 5, 2016 |
| Received | Oct 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153145
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.