Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K132180 |
Device Name |
IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
IDEAL LIFE INC. |
2995 STEVEN MARTIN DRIVE |
FAIRFAX,
VA
22031
|
|
Applicant Contact |
DAINE HORWITZ |
Correspondent |
IDEAL LIFE INC. |
2995 STEVEN MARTIN DRIVE |
FAIRFAX,
VA
22031
|
|
Correspondent Contact |
DAINE HORWITZ |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/15/2013 |
Decision Date | 06/25/2014 |
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
|
|
|