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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K172232
Device Name LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
Applicant
Ams Diagnostics
1790 N. Commerce Pkwy.
Weston,  FL  33326
Applicant Contact Samuel Burgos
Correspondent
Ams Diagnostics
1790 N. Commerce Pkwy.
Weston,  FL  33326
Correspondent Contact Samuel Burgos
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGX   CGZ   JJE  
Date Received07/25/2017
Decision Date 06/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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