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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 K113547
Model S60095 S5640081 S60096 S5640082 S5800084,S5800085
Device Name GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
Original Applicant
APEX BIOTECHNOLOGY CORP.
no. 7, li-hsin road v,
hsinchu science park
hsinchu,  TW 30078
Original Contact hsue-mei lee
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received12/01/2011
Decision Date 03/28/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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