The following data is part of a premarket notification filed by Worthington Diagnostic Systems with the FDA for Serum T4 By Enzyme Immunoassay.
| Device ID | K802573 |
| 510k Number | K802573 |
| Device Name: | SERUM T4 BY ENZYME IMMUNOASSAY |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | WORTHINGTON DIAGNOSTIC SYSTEMS 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 | 1980-10-17 |
| Decision Date | 1980-11-24 |