Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K083099 |
Device Name |
EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008 |
Applicant |
EPS BIO TECHNOLOGY CORP. |
2 F,NO. 49-2, LANE 2, SEC. 2, |
GUANG FU ROAD |
HSINCHU CITY,
TW
30071
|
|
Applicant Contact |
Y. C LEI |
Correspondent |
EPS BIO TECHNOLOGY CORP. |
2 F,NO. 49-2, LANE 2, SEC. 2, |
GUANG FU ROAD |
HSINCHU CITY,
TW
30071
|
|
Correspondent Contact |
Y. C LEI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/20/2008 |
Decision Date | 01/16/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|