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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 K230890
Device Name ISE Electrodes
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact Karena Shaw
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact Karena Shaw
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS  
Date Received03/31/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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