Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K161299 |
Device Name |
BGM014 Blood Glucose Monitoring System, BGM014 Pro 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 Codes |
|
Date Received | 05/09/2016 |
Decision Date | 12/23/2016 |
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
|
|
|