Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K120568 |
Device Name |
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
ARUL STERLIN |
Correspondent |
ABBOTT DIABETES CARE INC. |
1360 SOUTH LOOP RD. |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
ARUL STERLIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/27/2012 |
Decision Date | 03/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|