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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 Monitoring, Over-The-Counter
510(k) Number K233655
Device Name Lingo Glucose System
Applicant
Abbott
1360 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact Juni Sarkar
Correspondent
Abbott
1360 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact Juni Sarkar
Regulation Number862.1355
Classification Product Code
SAF  
Date Received11/14/2023
Decision Date 05/29/2024
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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