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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 K131727
Device Name CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Ceragem Medisys, Inc.
Cheonan Si, Chungcheongnam-Do,  KR 331-833
Applicant Contact HAKSUNG KIM
Correspondent
Ceragem Medisys, Inc.
Cheonan Si, Chungcheongnam-Do,  KR 331-833
Correspondent Contact HAKSUNG KIM
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   JQP   NBW  
Date Received06/12/2013
Decision Date 02/28/2014
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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