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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 K121433
Device Name GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
Original Applicant
HMD BIOMEDICAL, INC.
#181 minsheng street
xinpu township, hsinchu county,  TW 305
Original Contact jessica tung
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received05/14/2012
Decision Date 02/14/2013
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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