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510(k) K172232

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 by Ams Diagnostics — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2019
Date Received
July 25, 2017
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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