510(k) K993294 ยท LKJ Antinuclear Antibody, Antigen, Control
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Oct 25, 1999 |
| Received | Oct 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993294
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.