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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 K100437
Device Name AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
Applicant
Bestgen Biotech Corp.
7f, #186, Jian 1st Rd.,
Jhonghe City, Taipei County,  TW 23511
Applicant Contact STEVEN SHEN
Correspondent
Bestgen Biotech Corp.
7f, #186, Jian 1st Rd.,
Jhonghe City, Taipei County,  TW 23511
Correspondent Contact STEVEN SHEN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received02/17/2010
Decision Date 01/12/2012
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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