Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K160742 |
Device Name |
NoCoding1 Plus Blood Glucose Monitoring System |
Applicant |
i-SENS, INC. |
43, BANPO-DAER0 28-GIL, SEOCHO-GU |
SEOUL,
KR
06646
|
|
Applicant Contact |
Joon Ho Jung |
Correspondent |
i-SENS, INC. |
43, BANPO-DAER0 28-GIL, SEOCHO-GU |
SEOUL,
KR
06646
|
|
Correspondent Contact |
Joon Ho Jung |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/17/2016 |
Decision Date | 12/16/2016 |
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
|
|
|