The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Activecare Td-4121 Blood Glucose Monitoring System.
| Device ID | K173511 |
| 510k Number | K173511 |
| Device Name: | ActiveCare TD-4121 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 | Sheena Song |
| Correspondent | Anne Kuo 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 | 2017-11-13 |
| Decision Date | 2018-07-12 |
| Summary: | summary |