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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K103230
Device Name AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
Applicant
Bestgen Biotech Corp.
7f, No 186, Jian-Yi Rd.
Jung-He, Taipei County,  TW 235
Applicant Contact STEVEN SHEN
Correspondent
Bestgen Biotech Corp.
7f, No 186, Jian-Yi Rd.
Jung-He, Taipei County,  TW 235
Correspondent Contact STEVEN SHEN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received11/01/2010
Decision Date 04/24/2012
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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