Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K060793 |
Device Name |
ELEMENT BLOOD GLUCOSE TEST SYSTEM |
Applicant |
HOME DIAGNOSTICS, INC. |
2400 N.W. 55TH CT. |
FORT LAUDERDALE,
FL
33309
|
|
Applicant Contact |
KAREN DE VINCENT |
Correspondent |
HOME DIAGNOSTICS, INC. |
2400 N.W. 55TH CT. |
FORT LAUDERDALE,
FL
33309
|
|
Correspondent Contact |
KAREN DE VINCENT |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/23/2006 |
Decision Date | 07/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|