510(k) Premarket Notification Database
Device Classification Name |
cells, animal and human, cultured
|
510(k) Number | K841344 |
Device Name | ULTRACLONE ECL-01-300 CELL LINE |
Applicant |
EARL-CLAY LABORATORIES, INC.
|
|
Contact | |
Regulation Number | 864.2280 |
Classification Product Code |
|
Date Received | 04/02/1984 |
Decision Date | 05/11/1984 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Pathology
|
Review Advisory Committee |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|