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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K231679
Device Name CONTOUR® PLUS BLUE Blood Glucose Monitoring System
Applicant
Ascensia Diabetes Care
100 Summit Lake Dr.
Valhalla,  NY  10595
Applicant Contact Shahrir Alam
Correspondent
Ascensia Diabetes Care
100 Summit Lake Dr.
Valhalla,  NY  10595
Correspondent Contact Shahrir Alam
Regulation Number862.1345
Classification Product Code
NBW  
Date Received06/09/2023
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04008836
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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