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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 K102481
Device Name AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
Applicant
Apex BioTechnology Corp.
# 7, Li-Hsin Rd. V, Hsinchu Science Park
Hsinchu,  TW 30078
Applicant Contact LISA LIU
Correspondent
Apex BioTechnology Corp.
# 7, Li-Hsin Rd. V, Hsinchu Science Park
Hsinchu,  TW 30078
Correspondent Contact LISA LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received08/30/2010
Decision Date 04/28/2011
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
Predetermined Change
Control Plan Authorized		 No
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