Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K071493 |
Device Name |
CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 |
Applicant |
TaiDoc Technology Corporation |
4F, 88, SEC.1, KWANG FU ROAD |
SAN CHUNG,TAIPEI COUNTY R.O.C. |
SAN CHUNG, TAIPEI,
TW
241
|
|
Applicant Contact |
ERICA LI |
Correspondent |
TaiDoc Technology Corporation |
4F, 88, SEC.1, KWANG FU ROAD |
SAN CHUNG,TAIPEI COUNTY R.O.C. |
SAN CHUNG, TAIPEI,
TW
241
|
|
Correspondent Contact |
ERICA LI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/30/2007 |
Decision Date | 10/26/2007 |
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
|
|
|