FDA 510(k) Application Details - K051646

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K051646
Device Name	Electrode, Ion Specific, Sodium
Applicant	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US Other 510(k) Applications for this Company
Contact	WILLIAM F WALTERS Other 510(k) Applications for this Contact
Regulation Number	862.1665   More FDA Info for this Regulation Number
Classification Product Code	JGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2005
Decision Date	10/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review