The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco T3-quant Diag. Kit.
| Device ID | K834348 |
| 510k Number | K834348 |
| Device Name: | LEECO T3-QUANT DIAG. KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | LEECO 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 | 1983-12-13 |
| Decision Date | 1984-02-21 |