The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Magic 125i Digoxin Radioimmunoassay.
| Device ID | K840461 |
| 510k Number | K840461 |
| Device Name: | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DON |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-02 |
| Decision Date | 1984-03-23 |