Device Classification Name |
Colorimetric Method, Cpk Or Isoenzymes
|
510(k) Number |
K875192 |
Device Name |
KODAK EKTACHEM DT SLIDES (CKMB) |
Applicant |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650
|
|
Applicant Contact |
JOHN FERGUSON |
Correspondent |
EASTMAN KODAK COMPANY |
343 STATE ST. |
ROCHESTER,
NY
14650
|
|
Correspondent Contact |
JOHN FERGUSON |
Regulation Number | 862.1215 |
Classification Product Code |
|
Date Received | 12/17/1987 |
Decision Date | 02/24/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|