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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 K120649
Device Name AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
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 Code
CGA  
Date Received03/02/2012
Decision Date 07/06/2012
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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