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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 K132180
Device Name IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
Applicant
IDEAL LIFE INC.
2995 STEVEN MARTIN DRIVE
FAIRFAX,  VA  22031
Applicant Contact DAINE HORWITZ
Correspondent
IDEAL LIFE INC.
2995 STEVEN MARTIN DRIVE
FAIRFAX,  VA  22031
Correspondent Contact DAINE HORWITZ
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX   JQP  
Date Received07/15/2013
Decision Date 06/25/2014
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
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