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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
Device Name GLOOKO LOGBOOK CHARTS
Applicant
Glooko, Inc.
170a University Ave.
Palo Alto,  CA  94301
Applicant Contact SHILPA MYDUR
Correspondent
Glooko, Inc.
170a University Ave.
Palo Alto,  CA  94301
Correspondent 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 (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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