510(k) K253539 ยท NBC Test, Natriuretic Peptide
Alere NT-proBNP for Alinity i
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Feb 18, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253539
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.