510(k) K895964 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
DCL SYPHILIS-M CATALOG NO. 600-80
| Applicant | Diagnostic Chemicals, Ltd. (Usa), Oxford CT, US |
| Decision | Substantially Equivalent, Jan 8, 1991 |
| Received | Oct 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895964
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.