The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Ferritin 125i Radioimmunoassay.
| Device ID | K830591 |
| 510k Number | K830591 |
| Device Name: | CORNING FERRITIN 125I RADIOIMMUNOASSAY |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-24 |
| Decision Date | 1983-03-24 |