The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Bgm039 Blood Glucose Monitoring System, Bgm039 Link Blood Glucose Monitoring System.
| Device ID | K220421 |
| 510k Number | K220421 |
| Device Name: | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Apex BioTechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, CN 30078 |
| Contact | Lisa Liu |
| Correspondent | Lisa Liu Apex BioTechnology Corp. No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, CN 30078 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-14 |
| Decision Date | 2022-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894030002277 | K220421 | 000 |
| 00011822897679 | K220421 | 000 |
| 00011822897662 | K220421 | 000 |