Device Classification Name |
Glucose Dehydrogenase, Glucose
|
510(k) Number |
K101037 |
Device Name |
EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017 |
Applicant |
EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III |
HSINCHU SCIENCE PARK |
HSINCHU CITY,
TW
30077
|
|
Applicant Contact |
YC LEI |
Correspondent |
EPS BIO TECHNOLOGY CORP. |
NO.8 R&D RD III |
HSINCHU SCIENCE PARK |
HSINCHU CITY,
TW
30077
|
|
Correspondent Contact |
YC LEI |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/14/2010 |
Decision Date | 05/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|