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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K120064
Device Name TEST, BLOOD GLUCOSE SYSTEM
Applicant
HMD BIOMEDICAL, INC.
NO 181, MINGSHENG ST
XINPU TOWNSHIP, HSINCHU COUNTY,  TW 305
Applicant Contact JESSICA TUNG
Correspondent
HMD BIOMEDICAL, INC.
NO 181, MINGSHENG ST
XINPU TOWNSHIP, HSINCHU COUNTY,  TW 305
Correspondent Contact JESSICA TUNG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received01/09/2012
Decision Date 09/05/2012
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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