Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K153201 |
Device Name |
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System |
Applicant |
SD BIOSENSOR |
C-4th & 5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu |
Suwon-si,
KR
443-813
|
|
Applicant Contact |
Yeon Park |
Correspondent |
LK Consulting Group USA, Inc. |
2651 E Chapman Ave Ste 110 |
Fullerton,
CA
92831
|
|
Correspondent Contact |
Priscilla Chung |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/04/2015 |
Decision Date | 06/24/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|