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Document NumberK113307
Test Name GoodLife AC-305 Professional Blood Glucose Monitoring System  
Manufacturer NameHmd Biomedical, Inc.
Consumer Information Phone Number(855)692-3511
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date03/01/2013
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
Predetermined Change
Control Plan Authorized		 No
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