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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K203771
Device Name Urea Nitrogen2
Applicant
Abbott Ireland Diagnostics Division
Lisnamuch
Longford,  IE
Applicant Contact Tiffini Jenkins
Correspondent
Abbott Ireland Diagnostics Division
Lisnamuch
Longford,  IE
Correspondent Contact Tiffini Jenkins
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received12/23/2020
Decision Date 05/31/2022
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
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