510(k) K993839 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENA PROFILE ELISA TEST SYSTEM
| Applicant | Trinity Biotech USA, Jamestown NY, US |
| Decision | Substantially Equivalent, Jan 12, 2000 |
| Received | Nov 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993839
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.