510(k) K871548 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
CAPTIA(R) SYPHILIS-M
| Applicant | Mercia Diagnostics , Ltd., Guildford, Surrey England, GB |
| Decision | Substantially Equivalent, Aug 7, 1987 |
| Received | Apr 20, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871548
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.