FDA 510(k) Application Details - K060373

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K060373
Device Name	Electrode, Ion Specific, Potassium
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	KERWIN KAUFMAN 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	02/13/2006
Decision Date	03/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review