K202739 is an FDA 510(k) clearance for the Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Bioland Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 12, 2022, 693 days after receiving the submission on September 18, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K202739 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2020 |
| Decision Date | August 12, 2022 |
| Days to Decision | 693 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW - System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |