Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K112275 |
Device Name |
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD, |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Applicant Contact |
LINDA KO |
Correspondent |
TaiDoc Technology Corporation |
3F,5F, NO.127 WUGONG 2ND RD, |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Correspondent Contact |
LINDA KO |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/08/2011 |
Decision Date | 12/15/2011 |
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
|
|
|