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510(k) K093318

ACCELERATOR APS by Abbott Laboratories — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2010
Date Received
October 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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