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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 K121679
Device Name ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact MIKE FLIS
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact MIKE FLIS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received06/07/2012
Decision Date 10/11/2012
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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