510(k) K014233 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
CAPTIAM SYPHILIS-G ASSAY
| Applicant | Trinity Biotech, Plc, Co. Wicklow, IE |
| Decision | Substantially Equivalent, Jan 24, 2002 |
| Received | Dec 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014233
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.