GLOOKO LOGBOOK CHARTS


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K122142
Device Name GLOOKO LOGBOOK CHARTS
Applicant
GLOOKO, INC.
170a university avenue
palo alto, 
CA 
94301

Applicant Contact shilpa mydur
Correspondent
GLOOKO, INC.
170a university avenue
palo alto, 
CA 
94301

Correspodent Contact shilpa mydur
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 07/19/2012
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