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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK170079
Test Name Tyson Bioresearch, Inc., Tyson Bio HT100 Blood Glucose Monitoring System  
Manufacturer NameTyson Bioresearch, Inc.
Consumer Information Phone Number1(800)948-3894
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date10/12/2017
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K170079
Device Name Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
Applicant
Tyson Bioresearch, Inc.
5f, # 22, Ke E. Rd. Iii
Science-Based Industrial Park
Chu-Nan, Miao-Li County,  TW 350
Applicant Contact WEN-HAI TSAI
Correspondent
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 Received01/10/2017
Decision Date 10/06/2017
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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