Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K062347 |
Device Name |
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
BAYER HEALTHCARE, LLC |
430 SOUTH BEIGER ST. |
MISHAWAKA,
IN
46544
|
|
Applicant Contact |
MARC HENN |
Correspondent |
BAYER HEALTHCARE, LLC |
430 SOUTH BEIGER ST. |
MISHAWAKA,
IN
46544
|
|
Correspondent Contact |
MARC HENN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/10/2006 |
Decision Date | 11/22/2006 |
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
|
|
|