Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K043245 |
Device Name |
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM |
Applicant |
EPS BIO TECHNOLOGY CORP. |
3892 SOUTH AMERICA WEST TRAIL |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
EPS BIO TECHNOLOGY CORP. |
3892 SOUTH AMERICA WEST TRAIL |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/23/2004 |
Decision Date | 04/29/2005 |
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
|
|
|