Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K082618 |
Device Name |
ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455 |
Applicant |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
241
|
|
Applicant Contact |
Yuhua Chen |
Correspondent |
TaiDoc Technology Corporation |
6F, NO. 127, WUGONG 2ND RD |
WUGU TOWNSHIP |
TAIPEI COUNTY,
TW
241
|
|
Correspondent Contact |
Yuhua Chen |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/2008 |
Decision Date | 10/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|