Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K904768 |
Device Name |
KODATROL I AND II CONTROL AND DILUENT SET |
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 | 862.1660
|
Classification Product Code |
|
Date Received | 10/22/1990 |
Decision Date | 11/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|