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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K111268
Device Name CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Bayer Healthcare
430 S. Beiger St.
Mishawaka,  IN  46544
Applicant Contact WEIPING ZHONG
Correspondent
Bayer Healthcare
430 S. Beiger St.
Mishawaka,  IN  46544
Correspondent Contact WEIPING ZHONG
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received05/04/2011
Decision Date 03/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01264016
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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