Device Classification Name |
glucose dehydrogenase, glucose
|
510(k) Number |
K112901 |
Device Name |
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
Applicant |
EPS BIO TECHNOLOGY CORP. |
No.8, R&D Rd. III, |
Hsinchu Science Park, |
HSINCHU CITY,
TW
30077
|
|
Applicant Contact |
Cynthia Hung |
Correspondent |
EPS BIO TECHNOLOGY CORP. |
No.8, R&D Rd. III, |
Hsinchu Science Park, |
HSINCHU CITY,
TW
30077
|
|
Correspondent Contact |
Cynthia Hung |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/03/2011 |
Decision Date | 12/23/2011 |
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
|
|
|