FDA 510(k) Application Details - K162526

Device Classification Name	U.V. Method, Cpk Isoenzymes   More FDA Info for this Device
510(K) Number	K162526
Device Name	U.V. Method, Cpk Isoenzymes
Applicant	ROCHE DIAGNOSTICS 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	NOEL B. MENCIAS Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	JHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2016
Decision Date	05/26/2017
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