FDA 510(k) Application Details - K201312

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K201312
Device Name	Test,Natriuretic Peptide
Applicant	Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 US Other 510(k) Applications for this Company
Contact	Leah Van De Water 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	05/18/2020
Decision Date	10/04/2021
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