Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K042080 |
Device Name |
TRACKEASE SMART SYSTEM 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 | 862.1660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/03/2004 |
Decision Date | 08/19/2004 |
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
|
|
|