The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for T3 Uptake (t3u) Reagents.
| Device ID | K792607 |
| 510k Number | K792607 |
| Device Name: | T3 UPTAKE (T3U) REAGENTS |
| Classification | Radioassay, Triiodothyronine Uptake |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-18 |
| Decision Date | 1980-01-16 |