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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 K161834
Device Name One Drop Blood Glucose Monitoring System
Applicant
AgaMatrix, Inc.
7C Raymond Ave.
Salem,  NH  03079
Applicant Contact David Olsen
Correspondent
AgaMatrix, Inc.
7C Raymond Ave.
Salem,  NH  03079
Correspondent Contact David Olsen
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received07/05/2016
Decision Date 11/30/2016
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
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