Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K113547 |
Device Name |
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL |
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 | 12/01/2011 |
Decision Date | 03/28/2012 |
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
|
|
|