FDA 510(k) Application Details - K121823

Device Classification Name	Coulometric, Chloride   More FDA Info for this Device
510(K) Number	K121823
Device Name	Coulometric, Chloride
Applicant	WESCOR, INC. 370 West 1700 South Logan, UT 84321 US Other 510(k) Applications for this Company
Contact	DAWN T PERDUE Other 510(k) Applications for this Contact
Regulation Number	862.1170   More FDA Info for this Regulation Number
Classification Product Code	JFS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2012
Decision Date	03/27/2013
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