Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K162382 |
Device Name |
Smart Dongle Blood Glucose Monitoring System |
Applicant |
TaiDoc Technology Corporation |
B1-7F, No. 127, Wugong 2nd Rd., |
Wugu District |
new taipei city,
TW
24888
|
|
Applicant Contact |
paul liu |
Correspondent |
TaiDoc Technology Corporation |
B1-7F, No. 127, Wugong 2nd Rd., |
Wugu District |
new taipei city,
TW
24888
|
|
Correspondent Contact |
paul liu |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/24/2016 |
Decision Date | 04/14/2017 |
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
|
|
|