The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Td-4245 Blood Glucose Monitoring System, Td-4245.
| Device ID | K083664 |
| 510k Number | K083664 |
| Device Name: | FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen 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 | 2008-12-10 |
| Decision Date | 2009-01-09 |