Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K083263 |
Device Name |
SYMCARE DIABETES MANAGEMENT PROGRAM |
Applicant |
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC |
200 LAWRENCE DRIVE |
west chester,
PA
19380
|
|
Applicant Contact |
rae ann delay |
Correspondent |
SYMCARE PERSONALIZED HEALTH SOLUTIONS, INC |
200 LAWRENCE DRIVE |
west chester,
PA
19380
|
|
Correspondent Contact |
rae ann delay |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/05/2008 |
Decision Date | 03/13/2009 |
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
|
|
|