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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 K132272
Device Name GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
Applicant
GLOOKO, INC.
170A UNIVERSITY AVENUE
palo alto,  CA  94301
Applicant Contact shilpa mydur
Correspondent
GLOOKO, INC.
170A UNIVERSITY AVENUE
palo alto,  CA  94301
Correspondent Contact shilpa mydur
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received07/22/2013
Decision Date 10/17/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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