510(k) K881425 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
CAPTIA(R) SYPHILIS-G
| Applicant | Mercia Diagnostics , Ltd., Guildford, Surrey England, GB |
| Decision | Substantially Equivalent, Aug 4, 1988 |
| Received | Apr 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881425
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.