The following data is part of a premarket notification filed by Cryosan, Inc. with the FDA for Automated Blood Cell Separator.
| Device ID | K830831 |
| 510k Number | K830831 |
| Device Name: | AUTOMATED BLOOD CELL SEPARATOR |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | CRYOSAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-16 |
| Decision Date | 1983-06-16 |