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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090629
Test Name Tyson Bioresearch Inc. Easy Step Blood Glucose Monitoring System  
Manufacturer NameTyson Bioresearch, Inc.
Consumer Information Phone Number(800)948-3894
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/08/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090629
Device Name EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS
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
Tyson Bioresearch, Inc.
5f, # 22, Ke E. Rd. Iii
Science-Based Industrial Park
Chu-Nan, Miao-Li County,  TW 350
Correspondent Contact WEN-HAI TSAI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received03/09/2009
Decision Date 06/04/2009
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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