| Device Classification Name |
Chromatography (Liquid, Gel), Clinical Use
|
| 510(k) Number |
K851945 |
| Device Name |
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM |
| Applicant |
| Varian Assoc., Inc. |
| 611 Hansen Way |
| P.O. Box 10800 |
|
Palo Alto,
CA
94303
|
|
| Applicant Contact |
MILTON D DIEGEL |
| Correspondent |
| Varian Assoc., Inc. |
| 611 Hansen Way |
| P.O. Box 10800 |
|
Palo Alto,
CA
94303
|
|
| Correspondent Contact |
MILTON D DIEGEL |
| Regulation Number | 862.2260 |
| Classification Product Code |
|
| Date Received | 05/03/1985 |
| Decision Date | 05/24/1985 |
| 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
|
|
|