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
|
|
Correspondent Contact |
SHILPA MYDUR |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|