Device Classification Name |
glucose dehydrogenase, glucose
|
510(k) Number |
K051592 |
Device Name |
MODIFICATION TO ACCU-CHEK GO SYSTEM |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
DIMITRIS DEMIRTZOGLOU |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
DIMITRIS DEMIRTZOGLOU |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/15/2005 |
Decision Date | 09/02/2005 |
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
|
|
|