The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Advanced Gd40 Glucose, ß-ketone And Cholesterol Monitoring System.
| Device ID | K201037 |
| 510k Number | K201037 |
| Device Name: | FORA ADVANCED GD40 Glucose, ß-Ketone And Cholesterol Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | Jacky Chou |
| Correspondent | Jacky Chou TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Product Code | NBW |
| Subsequent Product Code | CHH |
| Subsequent Product Code | JIN |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-20 |
| Decision Date | 2022-06-16 |