Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K061992 |
Device Name |
EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014 |
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 Codes |
|
Date Received | 07/13/2006 |
Decision Date | 09/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|