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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 K072854
Device Name DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Tyson Bioresearch, Inc.
5 F., # 22, Ke Tung Rd.,
Science Based Industrial Park
Chun-Nan, Miao-Li County,  TW 350
Applicant Contact WEN-HAI TSAI
Correspondent
Tyson Bioresearch, Inc.
5 F., # 22, Ke Tung Rd.,
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 Received10/05/2007
Decision Date 06/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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