Device Classification Name |
System, Test, Blood Glucose, Over The Counter
More FDA Info for this Device |
510(K) Number |
K051854 |
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 |
SHU-MEI WU
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 |
07/08/2005 |
Decision Date |
08/05/2005 |
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 |
|