510(k) K052724

TECO ISE REAGENT SET FOR CX SYSTEM by Teco Diagnostics — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2005
Date Received
September 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type