510(k) K001525 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
| Applicant | Trinity Biotech, Plc, Jamestown NY, US |
| Decision | Substantially Equivalent, Nov 29, 2000 |
| Received | May 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001525
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.