The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Achtung Td-4207, Clever Chek Td-4209, Clever Chek Td-4222.
| Device ID | K042005 |
| 510k Number | K042005 |
| Device Name: | ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 |
| 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 | 2004-07-26 |
| Decision Date | 2004-08-27 |