FDA 510(k) Application Details - K130685

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K130685
Device Name	Catalytic Methods, Amylase
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	862.1070   More FDA Info for this Regulation Number
Classification Product Code	JFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2013
Decision Date	08/09/2013
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