The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Bioland G-425-2v Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System.
| Device ID | K202739 |
| 510k Number | K202739 |
| Device Name: | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong Longgang District Shenzhen, CN 518116 |
| Contact | Yiqing Feng |
| Correspondent | Eric Tan Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone, No. 5 Baolong Longgang District Shenzhen, CN 518116 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-18 |
| Decision Date | 2022-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939184630670 | K202739 | 000 |
| 16939184600694 | K202739 | 000 |
| 16939184600496 | K202739 | 000 |
| 16939184600489 | K202739 | 000 |
| 16939184630882 | K202739 | 000 |
| 16939184600946 | K202739 | 000 |
| 16939184601356 | K202739 | 000 |
| 16939184642526 | K202739 | 000 |