Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K160430 |
Device Name |
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System |
Applicant |
Ascensia Diabetes Care US Inc. |
430 South Beiger Street |
Mishawaka,
IN
46544
|
|
Applicant Contact |
Jennifer L. Gregory |
Correspondent |
Ascensia Diabetes Care US Inc. |
430 South Beiger Street |
Mishawaka,
IN
46544
|
|
Correspondent Contact |
Jennifer L. Gregory |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/16/2016 |
Decision Date | 06/24/2016 |
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
|
|
|