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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 K193407
Device Name Contour® next GEN Blood Glucose Monitoring System
Applicant
Ascensia Diabetes Care
100 Summit Lake Drive
Valhalla,  NY  10595
Applicant Contact Colleen Burdel
Correspondent
Ascensia Diabetes Care
100 Summit Lake Drive
Valhalla,  NY  10595
Correspondent Contact Colleen Burdel
Regulation Number862.1345
Classification Product Code
NBW  
Date Received12/09/2019
Decision Date 12/23/2021
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
Recalls CDRH Recalls
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