The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Single Step Free-t4 125i Radioimmuno-.
| Device ID | K823144 |
| 510k Number | K823144 |
| Device Name: | SINGLE STEP FREE-T4 125I RADIOIMMUNO- |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-25 |
| Decision Date | 1982-11-29 |