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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 K101204
Device Name MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION
Applicant
Apex BioTechnology Corp.
#7, Li-Hsin Rd. V, Hsinchu Science Park
Hsinchu,  TW 30078
Applicant Contact HSUE-MEI LEE
Correspondent
Apex BioTechnology Corp.
#7, Li-Hsin Rd. V, Hsinchu Science Park
Hsinchu,  TW 30078
Correspondent Contact HSUE-MEI LEE
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received04/30/2010
Decision Date 08/31/2011
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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