FDA 510(k) Application Details - K171498

Device Classification Name	System, Test, C-Reactive Protein   More FDA Info for this Device
510(K) Number	K171498
Device Name	System, Test, C-Reactive Protein
Applicant	Meso Scale Diagnostics, LLC 1601 Research Boulevard Rockville, MD 20850 US Other 510(k) Applications for this Company
Contact	Lillian Quintero Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2017
Decision Date	01/12/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review