The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immophase D-te 3 Radioimmunoassay.
| Device ID | K833406 |
| 510k Number | K833406 |
| Device Name: | IMMOPHASE D-TE 3 RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Estrone |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGF |
| CFR Regulation Number | 862.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-30 |
| Decision Date | 1984-01-24 |