FDA 510(k) Application Details - K013373

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K013373
Device Name	Electrode, Ion Specific, Potassium
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	JENNIFER TRIBETT 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	10/11/2001
Decision Date	11/02/2001
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