FDA 510(k) Application Details - K003668

Device Classification Name	Electrode, Ion-Specific, Chloride   More FDA Info for this Device
510(K) Number	K003668
Device Name	Electrode, Ion-Specific, Chloride
Applicant	WALLAC OY MUSTIONKATU 6 TURKU 20750 FI Other 510(k) Applications for this Company
Contact	GUNNEL LAAKSONEN 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	11/28/2000
Decision Date	02/12/2001
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