K220421 is an FDA 510(k) clearance for the BGM039 Blood Glucose Monitoring System, BGM039 Link 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 Apex BioTechnology Corp. (Hsinchu, CN). The FDA issued a Cleared decision on November 4, 2022, 263 days after receiving the submission on February 14, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K220421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2022 |
| Decision Date | November 04, 2022 |
| Days to Decision | 263 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 |