510(k) K041628 ยท LSW Anti-Dna Antibody, Antigen And Control
AESKULISA DS DNA G
| Applicant | Aesku Diagnostics, Miami FL, US |
| Decision | Substantially Equivalent, Oct 14, 2004 |
| Received | Jun 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041628
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.