The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4140 Smart Dongle Blood Glucose Plus B-ketone Monitoring System.
| Device ID | K173345 |
| 510k Number | K173345 |
| Device Name: | TD-4140 Smart Dongle Blood Glucose Plus B-ketone Monitoring System |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| 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 | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-24 |
| Decision Date | 2018-05-04 |
| Summary: | summary |