Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K132821 |
Device Name |
AGAMATRIX HEALTH MANAGER |
Applicant |
AGAMATRIX INC |
7C RAYMOND AVE |
SALEM,
NH
03079
|
|
Applicant Contact |
WILLIAM H MCGRAIL |
Correspondent |
AGAMATRIX INC |
7C RAYMOND AVE |
SALEM,
NH
03079
|
|
Correspondent Contact |
WILLIAM H MCGRAIL |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/2013 |
Decision Date | 11/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|