The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Nml-tetra-tube Ria.
| Device ID | K823053 |
| 510k Number | K823053 |
| Device Name: | NML-TETRA-TUBE RIA |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-18 |
| Decision Date | 1982-11-10 |