510(k) K041753 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
AESKULISA ENA 6 S
| Applicant | Aesku Diagnostics, Miami FL, US |
| Decision | Substantially Equivalent, Jul 14, 2004 |
| Received | Jun 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041753
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.