FDA 510(k) Application Details - K160724

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K160724
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	KATHLEEN DRAY-LYONS Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	CGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2016
Decision Date	09/07/2016
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