The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-4238 And Td-4246 Blood Glucose Monitoring System Fora G31 Blood Glucose Monitoring System, Td-4256 Blood Gluc.
| Device ID | K092902 |
| 510k Number | K092902 |
| Device Name: | U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Contact | Debra Liang |
| Correspondent | Debra Liang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-03-02 |
| Summary: | summary |