The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Ultra Trak Pro Blood Glucose Monitoring System, Model Td-455.
| Device ID | K082618 |
| 510k Number | K082618 |
| Device Name: | ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Contact | Yuhua Chen |
| Correspondent | Yuhua Chen TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2008-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00385930011082 | K082618 | 000 |
| 00385930011020 | K082618 | 000 |
| 00385930011013 | K082618 | 000 |