The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek Blood Glucose Monitoring System, Models Td-4209, -4222, -4225 And -4226 And Achtung Blood Glucose Monitoring.
| Device ID | K073494 |
| 510k Number | K073494 |
| Device Name: | CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-04-02 |
| Summary: | summary |