The following data is part of a premarket notification filed by Cetus Corporation with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK860025 |
| 510k Number | BK860025 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Cetus Corporation 1400 53rd Street Emeryville, CA 94608 |
| Product Code | KSZ |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-19 |
| Decision Date | 1987-04-27 |