The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Immu-tek Automatic Centrifuge.
| Device ID | K790767 |
| 510k Number | K790767 |
| Device Name: | IMMU-TEK AUTOMATIC CENTRIFUGE |
| Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSN |
| CFR Regulation Number | 864.9285 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-19 |
| Decision Date | 1979-05-23 |