Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K094005 |
Device Name |
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Applicant Contact |
NICKY PAN |
Correspondent |
TaiDoc Technology Corporation |
6F, 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 | 12/28/2009 |
Decision Date | 05/05/2010 |
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
|
|
|