FDA 510(k) Application Details - K142993

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K142993
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	ORION DIAGNOSTICA OY KIVIHARJUNTIE 11 4B OULU 90220 FI Other 510(k) Applications for this Company
Contact	ANJA KONTIO Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2014
Decision Date	03/10/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review