Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K081715 |
Device Name |
FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM |
Applicant |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Applicant Contact |
Yuhua Chen |
Correspondent |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Correspondent Contact |
Yuhua Chen |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/18/2008 |
Decision Date | 12/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|