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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 K110074
Device Name HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
Applicant
HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
CHUNG HO CITY, TAIPEI,  TW 235
Applicant Contact SARAH SU
Correspondent
HEALTH & LIFE CO., LTD.
9F, NO.186, JIAN YI ROAD
CHUNG HO CITY, TAIPEI,  TW 235
Correspondent Contact SARAH SU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received01/10/2011
Decision Date 05/25/2012
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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