Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K110017 |
Device Name |
AG-608N BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
ANDON MEDICAL CO., LTD. |
NO. 04-23-3 AIRPORT INDUSTRIAL |
PARK, TIANJIN |
TIANJIN,
CN
300381
|
|
Applicant Contact |
YI LIU |
Correspondent |
ANDON MEDICAL CO., LTD. |
NO. 04-23-3 AIRPORT INDUSTRIAL |
PARK, TIANJIN |
TIANJIN,
CN
300381
|
|
Correspondent Contact |
YI LIU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/03/2011 |
Decision Date | 01/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01268345
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|