Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K101457 |
Device Name |
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 |
Applicant |
EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III |
HSINCHU SCIENCE PARK |
HSINCHU CITY, HSINCHU,
TW
300
|
|
Applicant Contact |
Y.C. LEI |
Correspondent |
EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III |
HSINCHU SCIENCE PARK |
HSINCHU CITY, HSINCHU,
TW
300
|
|
Correspondent Contact |
Y.C. LEI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/26/2010 |
Decision Date | 07/01/2010 |
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
|
|
|