Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K101631 |
Device Name |
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D 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 Codes |
|
Date Received | 06/10/2010 |
Decision Date | 09/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|