The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Assay System, 125i Kit.
| Device ID | K781495 |
| 510k Number | K781495 |
| Device Name: | RIANEN ASSAY SYSTEM, 125I KIT |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
| Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DNL |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-30 |
| Decision Date | 1978-09-14 |