The following data is part of a premarket notification filed by International Business Machines with the FDA for Automated Blood Cell Separator -filtration.
| Device ID | BK820001 |
| 510k Number | BK820001 |
| Device Name: | Automated Blood Cell Separator -Filtration |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | International Business Machines Princeton, NJ 08540 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-19 |
| Decision Date | 1982-06-28 |