Device Classification Name |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
|
510(k) Number |
K903071 |
Device Name |
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN |
Applicant |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650
|
|
Applicant Contact |
NORMAN H GEIL |
Correspondent |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650
|
|
Correspondent Contact |
NORMAN H GEIL |
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 07/12/1990 |
Decision Date | 09/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|