Alere NT-proBNP for Alinity i Reagent Kit— 510(k) K241176

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K241176 for Alere NT-proBNP for Alinity i Reagent Kit, Substantially Equivalent on 2025-01-16. Applicant: Axis-Shield Diagnostics, Ltd..

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code NBC
Advisory panel: Clinical Chemistry
Date received: 2024-04-29
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

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