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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 K213131
Device Name Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Applicant
Roche Diabetes Care GmbH
Sandhofer Strasse 116
Mannheim,  DE 68305
Applicant Contact Wolfgang Handel
Correspondent
Roche Diabetes Care GmbH
9115 Hague Rd.
Indianapolis,,  IN  46250 -0457
Correspondent Contact Wolfgang Handel
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
NDC  
Date Received09/27/2021
Decision Date 08/10/2023
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
Predetermined Change
Control Plan Authorized		 No
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