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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K210452
Device Name Creatinine2
Applicant
Abbott Ireland Diagnostics Division
Lisnamuck
Longford,  IE
Applicant Contact Magdalena Suszko
Correspondent
Abbott Ireland Diagnostics Division
Lisnamuck
Longford,  IE
Correspondent Contact Magdalena Suszko
Regulation Number862.1225
Classification Product Code
CGX  
Date Received02/16/2021
Decision Date 03/22/2022
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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