| Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
| 510(K) Number |
K072489 |
| Device Name |
System, Test, Blood Glucose, Over The Counter |
| Applicant |
TaiDoc Technology Corporation
4F, 88, SEC.1, KWANG FU ROAD
SAN CHUNG, TAIPEI 241 TW
Other 510(k) Applications for this Company
|
| Contact |
ERICA LI
Other 510(k) Applications for this Contact |
| Regulation Number |
862.1345
More FDA Info for this Regulation Number |
| Classification Product Code |
NBW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
09/04/2007 |
| Decision Date |
09/20/2007 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
CH - Clinical Chemistry |
| Review Advisory Committee |
CH - Clinical Chemistry |
| Statement / Summary / Purged Status |
Statement |
| Type |
Special |
| Reviewed By Third Party |
N |
| Expedited Review |
|