Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K061181 |
Device Name |
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207 |
Applicant |
TaiDoc Technology Corporation |
4F, 88, SEC.1, KWANG FU ROAD |
SAN CHUNG, TAIPEI,
TW
241
|
|
Applicant Contact |
PI-SHIOU LI |
Correspondent |
TaiDoc Technology Corporation |
4F, 88, SEC.1, KWANG FU ROAD |
SAN CHUNG, TAIPEI,
TW
241
|
|
Correspondent Contact |
PI-SHIOU LI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/27/2006 |
Decision Date | 07/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|