510(k) K992552 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 16, 1999 |
| Received | Jul 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992552
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.