Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K093035 |
Device Name |
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244 |
Applicant |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Applicant Contact |
DEBRA LANG |
Correspondent |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
248
|
|
Correspondent Contact |
DEBRA LANG |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2009 |
Decision Date | 12/24/2009 |
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
|
|
|