510(k) K250408 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
Alegria Flash ENA Screen
| Applicant | Zeus Scientific, Branchburg NJ, US |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Feb 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250408
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.