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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 K182046
Device Name Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
Applicant
Tyson Bioresearch, Inc.
5f., # 16, 18, 20, 22, Kedong 3rd Rd.
Zhunan Township,  TW 35053
Applicant Contact Vance Chang
Correspondent
Dynamic Biotech, Inc. Dba. Ivdd Regulatory Consultant
29222 Rancho Viejo Rd.
Suite 218
San Juan Capistrano,  CA  92675
Correspondent Contact Feng-Yu Lee
Regulation Number862.1345
Classification Product Code
NBW  
Date Received07/31/2018
Decision Date 11/30/2018
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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