FDA 510(k) Application Details - K052724

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K052724
Device Name	Electrode, Ion Specific, Sodium
Applicant	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	JIAN VAECHES Other 510(k) Applications for this Contact
Regulation Number	862.1665   More FDA Info for this Regulation Number
Classification Product Code	JGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2005
Decision Date	12/14/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review