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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 K121190
Device Name CONTOUR NEXT BLOOD GLUCOSE METER
Applicant
BAYER HEALTHCARE LLC
555 WHITE PLAINS RD.
TARRYTOWN,  NY  10591
Applicant Contact CHARLES RYAN
Correspondent
BAYER HEALTHCARE LLC
555 WHITE PLAINS RD.
TARRYTOWN,  NY  10591
Correspondent Contact CHARLES RYAN
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received04/19/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Clinical Trials NCT01474317
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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