The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Choice Mini Blood Glucose Monitoring System Model Td-4265.
Device ID | K093941 |
510k Number | K093941 |
Device Name: | CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 |
Classification | Glucose Oxidase, Glucose |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Contact | Debra Liang |
Correspondent | Debra Liang TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 248 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-22 |
Decision Date | 2010-03-26 |
Summary: | summary |