Alere NT-proBNP for Alinity i— 510(k) K253539
Substantially EquivalentAxis-Shield Diagnostics, Ltd.
FDA 510(k) clearance K253539 for Alere NT-proBNP for Alinity i, Substantially Equivalent on 2026-02-18. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.
Summary
Axis-Shield Diagnostics' Alere NT-proBNP for Alinity i is filed under product code NBC, natriuretic peptide test. The record doesn't describe the test beyond its name and that code name.
Class II, 21 CFR 862.1117. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Axis-Shield Diagnostics filed from Dundee, United Kingdom. The decision came 97 calendar days after FDA received it (November 13, 2025 to February 18, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Product code
- Product code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Recent devices under product code NBC
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