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510(k) K153357

i-STAT Alinity System with i-STAT Sodium test by Abbott Point of Care, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2016
Date Received
November 20, 2015
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

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