The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Taidoc Check.
| Device ID | K041107 |
| 510k Number | K041107 |
| Device Name: | TAIDOC CHECK |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | TaiDoc Technology Corporation 4F, NO. 88, SEC.1, KWANG-FU RD SAN-CHUNG Taipei County, TW 241 |
| Contact | Shu-mei Wu |
| Correspondent | Shu-mei Wu TaiDoc Technology Corporation 4F, NO. 88, SEC.1, KWANG-FU RD SAN-CHUNG Taipei County, TW 241 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-28 |
| Decision Date | 2004-06-18 |
| Summary: | summary |