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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 K113137
Device Name GLUCOSE TEST SYSTEM
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact KHONESAVANH SAYSANA
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact KHONESAVANH SAYSANA
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received10/24/2011
Decision Date 01/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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