K253539
- 510(k) number
- K253539
- Device name
- Alere NT-proBNP for Alinity i
- Applicant
- Axis-Shield Diagnostics, Ltd. GB
- Product code
- NBC — Test, Natriuretic Peptide
- Decision date
- 2026-02-18
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253539.pdf
Official FDA record: K253539
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.