Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K100732 |
Device Name |
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241 |
Applicant |
TaiDoc Technology Corporation |
3F, 5F, NO 127 WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Applicant Contact |
NICKY PAN |
Correspondent |
TaiDoc Technology Corporation |
3F, 5F, NO 127 WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Correspondent Contact |
NICKY PAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/15/2010 |
Decision Date | 07/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|