Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K091481 |
Device Name |
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM |
Applicant |
EPS BIO TECHNOLOGY CORP. |
2 F,NO.49-2, LANE 2, SEC. 2, |
GUANG FU ROAD |
HSINCHU CITY,
TW
300
|
|
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
300
|
|
Correspondent Contact |
Y.C. LEI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/19/2009 |
Decision Date | 08/18/2009 |
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
|
|
|