FDA 510(k) Application Details - K141265

Device Classification Name	U.V. Method, Cpk Isoenzymes   More FDA Info for this Device
510(K) Number	K141265
Device Name	U.V. Method, Cpk Isoenzymes
Applicant	ELITECHGROUP 21720 23RD DR SE SUITE 150 BOTHELL, WA 98021 US Other 510(k) Applications for this Company
Contact	DEBRA K HUTSON 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	05/15/2014
Decision Date	07/18/2014
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