Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K141036 |
Device Name |
BGM009 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, |
HSINCHU SCIENCE PARK |
HSINCHU,
TW
30078
|
|
Applicant Contact |
HSUE-MEI LEE |
Correspondent |
APEX BIOTECHNOLOGY CORP. |
NO. 7, LI-HSIN ROAD V, |
HSINCHU SCIENCE PARK |
HSINCHU,
TW
30078
|
|
Correspondent Contact |
HSUE-MEI LEE |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/22/2014 |
Decision Date | 05/01/2015 |
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
|
|
|