| Device Classification Name |
Columns, Liquid Chromatography
|
| 510(k) Number |
K881868 |
| Device Name |
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD |
| Applicant |
| Supelco, Inc. |
| Supelco Park |
|
Bellefonte,
PA
16823 -0048
|
|
| Applicant Contact |
LLOYD A WITTING,PHD |
| Correspondent |
| Supelco, Inc. |
| Supelco Park |
|
Bellefonte,
PA
16823 -0048
|
|
| Correspondent Contact |
LLOYD A WITTING,PHD |
| Regulation Number | 862.2260 |
| Classification Product Code |
|
| Date Received | 05/03/1988 |
| Decision Date | 08/29/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Clinical Chemistry
|
| 510k Review Panel |
Toxicology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|