FDA 510(k) Application Details - K223637

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K223637
Device Name	Test,Natriuretic Peptide
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Jane Phillips 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	12/05/2022
Decision Date	07/21/2023
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