The following data is part of a premarket notification filed by Cytochem, Inc. with the FDA for Cytobucket Model 1024.
| Device ID | K810848 |
| 510k Number | K810848 |
| Device Name: | CYTOBUCKET MODEL 1024 |
| Classification | Cytocentrifuge |
| Applicant | CYTOCHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IFB |
| CFR Regulation Number | 864.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-27 |
| Decision Date | 1981-04-23 |