510(k) K040953 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
AESKULISA ANA HEP-2
| Applicant | Aesku, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jun 23, 2004 |
| Received | Apr 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040953
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.