510(k) K050590 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
ENZY-WELL SYPHILIS IGG, MODEL 91106
| Applicant | Diesse Diagnostica Senese S.P.A., Miami FL, US |
| Decision | Substantially Equivalent, Aug 10, 2006 |
| Received | Mar 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050590
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.