Alere NT-proBNP for Alinity i— 510(k) K253539

Substantially Equivalent

Axis-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..

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code NBC
Advisory panel: Clinical Chemistry
Date received: 2025-11-13
Decision date: 2026-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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