FDA 510(k) Application Details - K241176

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K241176
Device Name	Test,Natriuretic Peptide
Applicant	Axis-Shield Diagnostics Ltd 17 Luna Place The Technology Park Dundee DD2 1XA GB Other 510(k) Applications for this Company
Contact	Claire Dora Other 510(k) Applications for this Contact
Regulation Number	862.1117   More FDA Info for this Regulation Number
Classification Product Code	NBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2024
Decision Date	01/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review