The following data is part of a premarket notification filed by Cryosan, Inc. with the FDA for Automated Blood Cell Separator.
| Device ID | K822521 |
| 510k Number | K822521 |
| Device Name: | AUTOMATED BLOOD CELL SEPARATOR |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | CRYOSAN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-23 |
| Decision Date | 1982-09-30 |