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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Natriuretic Peptide
510(k) Number K241176
Device Name Alere NT-proBNP for Alinity i Reagent Kit
Applicant
Axis-Shield Diagnostics, Ltd.
17 Luna Pl.
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Abbott Laboratories
17 Luna Pl. The Technology Park
Dundee,  GB DD 1XA
Correspondent Contact Claire Dora
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
JIT   JJX  
Date Received04/29/2024
Decision Date 01/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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