FDA 510(k) Application Details - K131051

Device Classification Name	Turbidimetric, Total Protein   More FDA Info for this Device
510(K) Number	K131051
Device Name	Turbidimetric, Total Protein
Applicant	HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 US Other 510(k) Applications for this Company
Contact	ERIKA AMMIRATI Other 510(k) Applications for this Contact
Regulation Number	862.1635   More FDA Info for this Regulation Number
Classification Product Code	JGQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2013
Decision Date	06/07/2013
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