Device Classification Name |
Glucose Dehydrogenase, Glucose
|
510(k) Number |
K121224 |
Device Name |
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
TaiDoc Technology Corporation |
3F,5F, No.127, Wugong 2nd Rd. |
Wugu District |
New Taipei City,
TW
24888
|
|
Applicant Contact |
LINDA KO |
Correspondent |
TaiDoc Technology Corporation |
3F,5F, No.127, Wugong 2nd Rd. |
Wugu District |
New Taipei City,
TW
24888
|
|
Correspondent Contact |
LINDA KO |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/20/2012 |
Decision Date | 09/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|