|
Document Number | K101307 |
Test Name | Simple Diagnostics AG-6951 Multi Blood Glucose Monitoring System |
Manufacturer Name | ANDON MEDICAL CO., LTD. |
Consumer Information Phone Number | (877)342-2385 |
Test Type | Glucose monitoring devices (FDA cleared/home use) |
Effective Date | 08/16/2011 |
| |
Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K101307 |
Device Name |
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 |
Applicant |
ANDON MEDICAL CO., LTD. |
04-23-3 AIRPORT INDUSTRIAL PK |
TIANJIN,
CN
300381
|
|
Applicant Contact |
YI LIU |
Correspondent |
ANDON MEDICAL CO., LTD. |
04-23-3 AIRPORT INDUSTRIAL PK |
TIANJIN,
CN
300381
|
|
Correspondent Contact |
YI LIU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/10/2010 |
Decision Date | 08/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00976924
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|
|