The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Test, Ria, Triodothyronine.
| Device ID | K760057 |
| 510k Number | K760057 |
| Device Name: | TEST, RIA, TRIODOTHYRONINE |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-16 |
| Decision Date | 1976-09-13 |