The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Immufuge Disp. Liner.
| Device ID | K780281 |
| 510k Number | K780281 |
| Device Name: | IMMUFUGE DISP. LINER |
| Classification | Centrifuge, Blood-bank For In Vitro Diagnostic Use |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSO |
| CFR Regulation Number | 864.9275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-21 |
| Decision Date | 1978-03-02 |