The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for U-right Td-4249/u-right Td-4250 Blood Glucose Monitoring System.
Device ID | K083570 |
510k Number | K083570 |
Device Name: | U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM |
Classification | Glucose Oxidase, Glucose |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
Contact | Sophie Lin |
Correspondent | Sophie Lin TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 241 |
Product Code | CGA |
Subsequent Product Code | JJX |
Subsequent Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-12-03 |
Decision Date | 2009-03-11 |