The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-4116 Blood Glucose Monitoring System, U-right Td-4116 Pro Blood Glucose Monitoring System.
| Device ID | K151100 |
| 510k Number | K151100 |
| Device Name: | U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TAIDOC TECHNOLOGY CORPORATION B1-7F , No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | C.w. Chen |
| Correspondent | Paul Liu TAIDOC TECHNOLOGY CORPORATION B1-7F , No.127, Wugong 2nd Rd., Wugu District New Taipei City, 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 | 2015-04-24 |
| Decision Date | 2015-09-29 |
| Summary: | summary |