510(k) K910487 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
VISUWELL SYPHILIS ANTIGEN
| Applicant | Adi Diagnostics, Inc., Rexdale, Ontario, CA |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | Feb 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910487
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.