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 |