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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose dehydrogenase, glucose
510(k) Number K113307
Device Name GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
Applicant
HMD BIOMEDICAL, INC.
No 181 Minsheng St, Xinpu Township
Hsinchu County,  TW 305
Applicant Contact JESSICA TUNG
Correspondent
HMD BIOMEDICAL, INC.
No 181 Minsheng St, Xinpu Township
Hsinchu County,  TW 305
Correspondent Contact JESSICA TUNG
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received11/08/2011
Decision Date 07/27/2012
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
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