Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K163159 |
Device Name |
Dario Blood Glucose Monitoring System |
Applicant |
LabStyle Innovations, Ltd. |
9 Halamish Street, North Industrial Park |
caesarea,
IL
3890000
|
|
Applicant Contact |
erez raphael |
Correspondent |
Qualtra Consulting, Inc. |
5 Casie Lane |
pepperell,
MA
01463
|
|
Correspondent Contact |
tracey wielinski |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 11/10/2016 |
Decision Date | 07/19/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
summary |
summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02910674 NCT02916563
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|