The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Magic Tm 125i T3 Uptake Radioassay.
| Device ID | K831613 |
| 510k Number | K831613 |
| Device Name: | MAGIC TM 125I T3 UPTAKE RADIOASSAY |
| Classification | Radioassay, Triiodothyronine Uptake |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-19 |
| Decision Date | 1983-08-11 |