The following data is part of a premarket notification filed by New England Nuclear with the FDA for Assay System, Ferritin I Kit.
| Device ID | K781888 |
| 510k Number | K781888 |
| Device Name: | ASSAY SYSTEM, FERRITIN I KIT |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Applicant | NEW ENGLAND NUCLEAR 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 | 1978-11-07 |
| Decision Date | 1979-01-10 |