The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Magic Single Step Free T4.
| Device ID | K832381 |
| 510k Number | K832381 |
| Device Name: | CORNING MAGIC SINGLE STEP FREE T4 |
| 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 | 1983-07-19 |
| Decision Date | 1983-09-01 |