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510(k) K172232

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

K172232 is an FDA 510(k) premarket notification submitted by Ams Diagnostics for the device "LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600". The FDA issued a decision of Substantially Equivalent on June 12, 2019. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665.

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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FDA data resources