Device Classification Name |
system, test, blood glucose, over the counter
|
510(k) Number |
K081389 |
Device Name |
ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
Roche Diagnostics |
9115 HAGUE ROAD |
INDIANAPOLIS,
IN
46256
|
|
Applicant Contact |
Scott Thiel |
Correspondent |
Roche Diagnostics |
9115 HAGUE ROAD |
INDIANAPOLIS,
IN
46256
|
|
Correspondent Contact |
Scott Thiel |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/19/2008 |
Decision Date | 07/15/2008 |
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
|
|
|