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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK101543
Test Name Tyson Bio AC200 Blood Glucose Monitoring System  
Manufacturer NameTYSON BIORESEARCH, INC.
Consumer Information Phone Number1(800)948-3894
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date09/06/2011
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K101543
Device Name TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200
Applicant
TYSON BIORESEARCH, INC.
5F, #22, KE E. ROAD, III
SCIENCE-BASED INDUSTRIAL PARK
CHUN-NAN, MIAO-LI COUNTY,  TW 350
Applicant Contact WEN-HAI TSAI
Correspondent
TYSON BIORESEARCH, INC.
5F, #22, KE E. ROAD, III
SCIENCE-BASED INDUSTRIAL PARK
CHUN-NAN, MIAO-LI COUNTY,  TW 350
Correspondent Contact WEN-HAI TSAI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received06/03/2010
Decision Date 08/30/2011
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
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