Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K031260 |
Device Name |
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 |
Applicant |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. |
ALAMEDA,
CA
94502 -7000
|
|
Applicant Contact |
DONNA K TEMPLEMAN |
Correspondent |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. |
ALAMEDA,
CA
94502 -7000
|
|
Correspondent Contact |
DONNA K TEMPLEMAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/21/2003 |
Decision Date | 12/19/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|