Device Classification Name |
Glucose Dehydrogenase, Glucose
|
510(k) Number |
K112272 |
Device Name |
EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
Applicant |
EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III |
HSINCHU SCIENCE PARK |
HSINCHU CITY, HSINCHU,
TW
30077
|
|
Applicant Contact |
YC LEI |
Correspondent |
EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III |
HSINCHU SCIENCE PARK |
HSINCHU CITY, HSINCHU,
TW
30077
|
|
Correspondent Contact |
YC LEI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/08/2011 |
Decision Date | 09/07/2011 |
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
|
|
|