| Device Classification Name |
Station, Pipetting And Diluting, For Clinical Use
|
| 510(k) Number |
K902592 |
| Device Name |
EPC ELECTRONIC PIPETTING SYSTEM |
| Applicant |
| Ulster Scientific, Inc. |
| P.O. Box 902 |
|
Highland,
NY
12528
|
|
| Applicant Contact |
RICHARD CUNNINGHAM |
| Correspondent |
| Ulster Scientific, Inc. |
| P.O. Box 902 |
|
Highland,
NY
12528
|
|
| Correspondent Contact |
RICHARD CUNNINGHAM |
| Regulation Number | 862.2750 |
| Classification Product Code |
|
| Date Received | 06/12/1990 |
| Decision Date | 07/19/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Clinical Chemistry
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|