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510(k) K181201

Synermed ISE Reagents by Infrared Laboratory Systems, LLC (Dba Synermed) — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2018
Date Received
May 7, 2018
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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