Device Classification Name |
System, Test, Blood Glucose, Over The Counter
|
510(k) Number |
K121679 |
Device Name |
ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
MIKE FLIS |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
MIKE FLIS |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2012 |
Decision Date | 10/11/2012 |
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
|
|
|