The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Radioimmunoassay Test System.
| Device ID | K791096 |
| 510k Number | K791096 |
| Device Name: | RADIOIMMUNOASSAY TEST SYSTEM |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-12 |
| Decision Date | 1979-08-03 |