Device Classification Name |
Alkaline Picrate, Colorimetry, Creatinine
|
510(k) Number |
K934071 |
Device Name |
KODAK EKTACHEM DT SLIDES (URCR) |
Applicant |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650 -1131
|
|
Applicant Contact |
BRADFORD M SPRING |
Correspondent |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650 -1131
|
|
Correspondent Contact |
BRADFORD M SPRING |
Regulation Number | 862.1225
|
Classification Product Code |
|
Date Received | 08/20/1993 |
Decision Date | 03/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|