The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Fora Md6 Uric Acid Monitoring System, Fora Md6 Pro Uric Acid Monitoring System.
| Device ID | K181675 |
| 510k Number | K181675 |
| Device Name: | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System |
| Classification | Uric Acid Test System For At Home Prescription Use |
| Applicant | TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Contact | Yvette Chang |
| Correspondent | Yvette Chang TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, TW 24888 |
| Product Code | PTC |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2018-12-10 |
| Summary: | summary |