FDA 510(k) Application Details - K052027

Device Classification Name	Electrode, Ion-Specific, Chloride   More FDA Info for this Device
510(K) Number	K052027
Device Name	Electrode, Ion-Specific, Chloride
Applicant	OSMETECH, INC. 235 HEMBREE PARK DRIVE ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	DANIEL MCMINN Other 510(k) Applications for this Contact
Regulation Number	862.1170   More FDA Info for this Regulation Number
Classification Product Code	CGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2005
Decision Date	09/29/2005
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