FDA 510(k) Application Details - K232164

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K232164
Device Name	Test,Natriuretic Peptide
Applicant	Beckman Coulter Inc. 1000 Lake Hazeltine Dr. Chaska, MN 55331 US Other 510(k) Applications for this Company
Contact	Rachel Clark 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	07/21/2023
Decision Date	04/12/2024
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