The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-4280 Blood Glucose Monitoring System.
| Device ID | K113768 |
| 510k Number | K113768 |
| Device Name: | U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP New Taipei City, TW 248 |
| Contact | Meiru Li |
| Correspondent | Meiru Li TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP New Taipei City, TW 248 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-04-12 |
| Summary: | summary |