Device Classification Name |
nadh oxidation/nad reduction, ast/sgot
|
510(k) Number |
K934413 |
Device Name |
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE |
Applicant |
EASTMAN KODAK COMPANY |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14652 -0882
|
|
Applicant Contact |
YVONNE E MIDDLEFELL |
Correspondent |
EASTMAN KODAK COMPANY |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14652 -0882
|
|
Correspondent Contact |
YVONNE E MIDDLEFELL |
Regulation Number | 862.1100
|
Classification Product Code |
|
Date Received | 09/10/1993 |
Decision Date | 04/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|