510(k) K053570 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
TREP-SURE TREPONEMAL ANTIBODY EIA
| Applicant | Phoenix Biotech Corp., East Stroudsburg PA, US |
| Decision | Substantially Equivalent, Aug 7, 2006 |
| Received | Dec 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053570
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.