The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek Td-4225, Model Td-4225.
| Device ID | K051854 |
| 510k Number | K051854 |
| Device Name: | CLEVER CHEK TD-4225, MODEL TD-4225 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
| Contact | Shu-mei Wu |
| Correspondent | Shu-mei Wu TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-08 |
| Decision Date | 2005-08-05 |