The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek Td-4230 Blood Glucose Monitoring System, Rd-4230, Surechek Blood Glucose Monitoring System, Sms-4230.
| Device ID | K070472 |
| 510k Number | K070472 |
| Device Name: | CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230 |
| 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 | Erica Li |
| Correspondent | Erica 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 | 2007-02-20 |
| Decision Date | 2007-03-15 |