Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K101509 |
Device Name |
U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD, |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
24888
|
|
Applicant Contact |
TELING HSU |
Correspondent |
TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD, |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
24888
|
|
Correspondent Contact |
TELING HSU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2010 |
Decision Date | 06/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|