The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Gal-1a Plus Blood Glucose Monitoring System.
| Device ID | K213887 |
| 510k Number | K213887 |
| Device Name: | GAL-1A Plus 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 | 2021-12-13 |
| Decision Date | 2022-03-29 |