The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4183 Blood Glucose Monitoring System.
| Device ID | K190579 |
| 510k Number | K190579 |
| Device Name: | TD-4183 Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | Sophia Wu |
| Correspondent | Sophia Wu TaiDoc Technology Corporation 6F, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-06 |
| Decision Date | 2019-06-04 |