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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K252357
Device Name Glucose2
Applicant
Abbott Ireland
Diagnostics Division
Lisnamuck
Longford,  IE
Applicant Contact Cherie Lipowsky
Correspondent
Abbott Ireland
Diagnostics Division
Lisnamuck
Longford,  IE
Correspondent Contact Cherie Lipowsky
Regulation Number862.1345
Classification Product Code
CFR  
Date Received07/29/2025
Decision Date 10/24/2025
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		 Yes
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