Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K032657 |
Device Name |
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH) |
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 Codes |
|
Date Received | 08/28/2003 |
Decision Date | 03/24/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|