The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Chek And Audiochek Blood Glucose Monitoring Systems, Model Td-4237.
| Device ID | K081609 |
| 510k Number | K081609 |
| Device Name: | CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237 |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-09 |
| Decision Date | 2008-07-02 |