510(k) K170320

Alinity c ICT Sample Diluent by Abbott Laboratories — Product Code CGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2017
Date Received
February 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion-Specific, Chloride
Device Class
Class II
Regulation Number
862.1170
Review Panel
CH
Submission Type