The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Clever Choice Auto-code Pro Blood Glucose Monitoring System Model Td-4267.
Device ID | K093506 |
510k Number | K093506 |
Device Name: | CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 |
Classification | Glucose Oxidase, Glucose |
Applicant | TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
Contact | Teling Hsu |
Correspondent | Teling Hsu TaiDoc Technology Corporation 6F, NO. 127, WUGONG 2ND RD WUGU TOWNSHIP Taipei County, TW 24888 |
Product Code | CGA |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-12 |
Decision Date | 2010-04-01 |
Summary: | summary |