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U.S. Department of Health and Human Services

Devices@FDA
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Device Classification Name Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
510(k) Number K233861
Device Name Libre Rio Continuous Glucose Monitoring System
Applicant
Abbott Diabetes Care
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact Tenzin Ngadon
Correspondent
Abbott Diabetes Care
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact Tenzin Ngadon
Regulation Number862.1355
Classification Product Code
SBH  
Date Received12/06/2023
Decision Date 06/07/2024
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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