The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Immuno-cell Immuno-sep Kit.
| Device ID | K812411 |
| 510k Number | K812411 |
| Device Name: | IMMUNO-CELL IMMUNO-SEP KIT |
| Classification | Lymphocyte Separation Medium |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JCF |
| CFR Regulation Number | 864.8500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-21 |
| Decision Date | 1981-11-10 |