The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Unival Control Cells.
| Device ID | K761284 |
| 510k Number | K761284 |
| Device Name: | UNIVAL CONTROL CELLS |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-20 |
| Decision Date | 1977-01-25 |