K894993 is an FDA 510(k) clearance for the STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II - Special Controls, product code CDP).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on October 13, 1989, 66 days after receiving the submission on August 8, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1710.
| 510(k) Number | K894993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1989 |
| Decision Date | October 13, 1989 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1710 |