The following data is part of a premarket notification filed by Activated Cell Therapy Inc. with the FDA for Lymphocyte Separation Medium.
| Device ID | BK960002 |
| 510k Number | BK960002 |
| Device Name: | Lymphocyte Separation Medium |
| Classification | Lymphocyte Separation Medium |
| Applicant | Activated Cell Therapy Inc. 291 North Bernardo Avenue Mountain View, CA 94043 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-03 |
| Decision Date | 1996-08-12 |