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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 K160944
Device Name ACCU-CHEK Guide Blood Glucose Monitoring System
Applicant
Roche Diabetes Care, Inc.
9115 Hague Road
Indianapolis,  IN  46250 -0457
Applicant Contact Khone Saysana
Correspondent
Roche Diabetes Care, Inc.
9115 Hague Road
Indianapolis,  IN  46250 -0457
Correspondent Contact Khone Saysana
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received04/05/2016
Decision Date 08/31/2016
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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