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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 K123087
Device Name TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Tyson Bioresearch, Inc.
5 F., # 22, Ke E. Rd. Iii
Science Based Industrial Park
Chun-Nan, Miao-Li County,  TW 350
Applicant Contact WEN-HAI TSAI
Correspondent
Tyson Bioresearch, Inc.
5 F., # 22, Ke E. Rd. 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 Codes
CGA   JJX  
Date Received10/01/2012
Decision Date 06/18/2013
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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