| Device Classification Name |
Station, Pipetting And Diluting, For Clinical Use
|
| 510(k) Number |
K844798 |
| Device Name |
EPPENDORF DILUTER |
| Applicant |
| Medical Technomics, Ltd. |
| 770-D N. Church Rd. |
|
Elmhurst,
IL
60126
|
|
| Applicant Contact |
DENNIS A ALDRED |
| Correspondent |
| Medical Technomics, Ltd. |
| 770-D N. Church Rd. |
|
Elmhurst,
IL
60126
|
|
| Correspondent Contact |
DENNIS A ALDRED |
| Regulation Number | 862.2750 |
| Classification Product Code |
|
| Date Received | 12/11/1984 |
| Decision Date | 01/07/1985 |
| 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
|
|
|