The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Td-4257 Blood Glucose Monitoring Systems,td 4257 Multi Blood Glucose Monitoring Systems.
| Device ID | K112963 |
| 510k Number | K112963 |
| Device Name: | TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Contact | Teling Hsu |
| Correspondent | Teling Hsu TaiDoc Technology Corporation 3F,5F, 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 | 2011-10-05 |
| Decision Date | 2011-11-22 |
| Summary: | summary |