FDA 510(k) Application Details - K182702

Device Classification Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K182702
Device Name	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant	SEKISUI DIAGNOSTICS P.E.I. INC. 70 Watts Avenue Charlottetown C1E 2B9 CA Other 510(k) Applications for this Company
Contact	Jeanna MacLeod 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	09/27/2018
Decision Date	04/17/2019
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