FDA 510(k) Application Details - K061730

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K061730
Device Name	Electrode, Ion Specific, Potassium
Applicant	OSMETECH, INC. 235 HEMBREE PARK DRIVE ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	BERNIE HEITZ Other 510(k) Applications for this Contact
Regulation Number	862.1600   More FDA Info for this Regulation Number
Classification Product Code	CEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2006
Decision Date	08/04/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review