The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Td-4251/u-right Td-4252/u-right Td-4254 Blood Glucose Monitoring System, Model Td-4251/td-4252a/td-4252b/td-4254.
| Device ID | K082482 |
| 510k Number | K082482 |
| Device Name: | FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Sophie Lin |
| Correspondent | Sophie Lin TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-28 |
| Decision Date | 2009-01-30 |