Device Classification Name |
hexokinase, glucose
|
510(k) Number |
K092603 |
Device Name |
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
KATHIE J GOODWIN |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
KATHIE J GOODWIN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 08/25/2009 |
Decision Date | 12/04/2009 |
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
|
|
|