Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Test, Natriuretic Peptide
510(k) Number K253539
Device Name Alere NT-proBNP for Alinity i
Applicant
Axis-Shield Diagnostics, Ltd.
17 Luna Place
The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Axis-Shield Diagnostics, Ltd.
17 Luna Place
The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number862.1117
Classification Product Code
NBC  
Date Received11/13/2025
Decision Date 02/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-