The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek Td-4231 And Td-4223 Blood Glucose Monitoring System.
| Device ID | K063212 |
| 510k Number | K063212 |
| Device Name: | CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM |
| 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 |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2006-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066005057 | K063212 | 000 |
| 00385930000017 | K063212 | 000 |
| 00385930000000 | K063212 | 000 |
| 00722066003213 | K063212 | 000 |
| 00722066004692 | K063212 | 000 |
| 00722066003190 | K063212 | 000 |
| 00722066003183 | K063212 | 000 |
| 00722066003176 | K063212 | 000 |