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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, Potassium
510(k) Number K200544
Device Name SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Applicant
Diamond Diagnostics, Inc.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact Kathy Fisher
Correspondent
Diamond Diagnostics, Inc.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact Kathy Fisher
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JFP   JGS   JIH   JJE  
Date Received03/03/2020
Decision Date 10/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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