Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K191286 |
Device Name |
CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System |
Applicant |
Ascensia Diabetes Care |
100 Summit Lake Drive |
Valhalla,
NY
10595
|
|
Applicant Contact |
Stacie Geffner-Atiya |
Correspondent |
Ascensia Diabetes Care |
100 Summit Lake Drive |
Valhalla,
NY
10595
|
|
Correspondent Contact |
Stacie Geffner-Atiya |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 05/13/2019 |
Decision Date | 11/08/2019 |
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
|
|
|