The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Uright Hemoglobin A1c System, Fora A1c System.
| Device ID | K142664 |
| 510k Number | K142664 |
| Device Name: | URight Hemoglobin A1c System, FORA A1c System |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 6F, No. 127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Product Code | LCP |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-18 |
| Decision Date | 2016-01-29 |
| Summary: | summary |