Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K080853 |
Device Name |
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM |
Applicant |
GENEXEL-SEIN, INC. |
845 ARONSON LAKE COURT |
ROSWELL,
GA
30075
|
|
Applicant Contact |
JAY MANSOUR |
Correspondent |
GENEXEL-SEIN, INC. |
845 ARONSON LAKE COURT |
ROSWELL,
GA
30075
|
|
Correspondent Contact |
JAY MANSOUR |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/26/2008 |
Decision Date | 02/20/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|