Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K090495 |
Device Name |
TRUEBALANCE BLOOD GLUCOSE SYSTEM |
Applicant |
HOME DIAGNOSTICS, INC. |
2400 N.W. 55TH CT. |
FORT LAUDERDALE,
FL
33309
|
|
Applicant Contact |
KAREN DEVINCENT |
Correspondent |
HOME DIAGNOSTICS, INC. |
2400 N.W. 55TH CT. |
FORT LAUDERDALE,
FL
33309
|
|
Correspondent Contact |
KAREN DEVINCENT |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/25/2009 |
Decision Date | 03/27/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|