The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek Td-3213/ Clever Chek Td-3215/ Dr. T Td-3216/ Clever Chek Td-3217/ Clever Chek Td-3250 Blood Glucose Plus Blo.
| Device ID | K062800 |
| 510k Number | K062800 |
| Device Name: | CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO |
| 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 | Pi-shiou Li |
| Correspondent | Pi-shiou Li TaiDoc Technology Corporation 4F, 88, SEC.1, KWANG FU ROAD San Chung, Taipei, TW 241 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-19 |
| Decision Date | 2007-01-12 |
| Summary: | summary |