FDA 510(k) Application Details - K120945

Device Classification Name	Nadh Oxidation/Nad Reduction, Alt/Sgpt   More FDA Info for this Device
510(K) Number	K120945
Device Name	Nadh Oxidation/Nad Reduction, Alt/Sgpt
Applicant	HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	CHARLES TSOU Other 510(k) Applications for this Contact
Regulation Number	862.1030   More FDA Info for this Regulation Number
Classification Product Code	CKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2012
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