Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K202739 |
Device Name |
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System |
Applicant |
Bioland Technology Ltd. |
No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong |
Longgang District |
Shenzhen,
CN
518116
|
|
Applicant Contact |
Yiqing Feng |
Correspondent |
Bioland Technology Ltd. |
No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong |
Longgang District |
Shenzhen,
CN
518116
|
|
Correspondent Contact |
Eric Tan |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 09/18/2020 |
Decision Date | 08/12/2022 |
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
|
|
|