FDA 510(k) Application Details - K020364

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K020364
Device Name	Electrode, Ion Specific, Sodium
Applicant	PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	RAN NUNNA 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	02/04/2002
Decision Date	06/04/2002
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