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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 K120448
Device Name MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
Applicant
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Applicant Contact LISA LIU
Correspondent
APEX BIOTECHNOLOGY CORP.
NO. 7, LI-HSIN ROAD V,
HSINCHU SCIENCE PARK
HSINCHU,  TW 30078
Correspondent Contact LISA LIU
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received02/14/2012
Decision Date 04/06/2012
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
Recalls CDRH Recalls
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