510(k) K213486

GLP systems Track by Abbott Laboratories — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2022
Date Received
October 29, 2021
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