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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 K122142
Model GLC
Device Name GLOOKO LOGBOOK CHARTS
Applicant
GLOOKO, INC.
170a university avenue
palo alto,  CA  94301
Contact shilpa mydur
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received07/19/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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