Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K092602 |
FOIA Releasable 510(k) |
K092602
|
Device Name |
FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite 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 | 08/25/2009 |
Decision Date | 05/14/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|