Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K113077 |
Device Name |
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TaiDoc Technology Corporation |
3F, 5F, NO 127 WUGONG 2ND RD |
WUGU TOWNSHIP, WUGU DIST |
NEW TAIPEI CITY,
TW
24888
|
|
Applicant Contact |
LINDA KO |
Correspondent |
TaiDoc Technology Corporation |
3F, 5F, NO 127 WUGONG 2ND RD |
WUGU TOWNSHIP, WUGU DIST |
NEW TAIPEI CITY,
TW
24888
|
|
Correspondent Contact |
LINDA KO |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/17/2011 |
Decision Date | 08/03/2012 |
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
|
|
|