Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K153330 |
Device Name |
FreeStyle Precision Neo H Blood Glucose Monitoring System |
Applicant |
Abbott Diabetes Care Inc. |
1360 South Loop Road |
Alameda,
CA
94202
|
|
Applicant Contact |
Arul Sterlin |
Correspondent |
Abbott Diabetes Care Inc. |
1360 South Loop Road |
Alameda,
CA
94202
|
|
Correspondent Contact |
Arul Sterlin |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/19/2015 |
Decision Date | 02/19/2016 |
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
|
|
|