FDA 510(k) Application Details - K220265

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K220265
Device Name	Test,Natriuretic Peptide
Applicant	Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown, NY 10591 US Other 510(k) Applications for this Company
Contact	Asha Gartland 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	01/31/2022
Decision Date	09/24/2023
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