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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 K102751
Device Name LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Ceragem Medisys, Inc.
3699 Wilshire Blvd., Suite 930
Los Angeles,  CA  90010
Applicant Contact GRACE KIM
Correspondent
Ceragem Medisys, Inc.
3699 Wilshire Blvd., Suite 930
Los Angeles,  CA  90010
Correspondent Contact GRACE KIM
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received09/23/2010
Decision Date 02/11/2013
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
Predetermined Change
Control Plan Authorized		 No
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