The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immo Phase Ft4 Assay.
| Device ID | K772194 |
| 510k Number | K772194 |
| Device Name: | IMMO PHASE FT4 ASSAY |
| 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 | 1977-11-28 |
| Decision Date | 1978-01-06 |