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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 K113243
Device Name EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
Applicant
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY,  TW 30077
Applicant Contact Cynthia Hung
Correspondent
EPS BIO TECHNOLOGY CORP.
NO.8 R&D RD III
HSINCHU SCIENCE PARK
HSINCHU CITY,  TW 30077
Correspondent Contact Cynthia Hung
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received11/02/2011
Decision Date 03/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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