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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 K113314
Device Name PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Hmd Biomedical, Inc.
# 181
Minsheng St.
Xinpu Township, Hsinchu County,  TW 30542
Applicant Contact Wang YunHan
Correspondent
Hmd Biomedical, Inc.
# 181
Minsheng St.
Xinpu Township, Hsinchu County,  TW 30542
Correspondent Contact Wang YunHan
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
JJX  
Date Received11/09/2011
Decision Date 11/09/2012
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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