The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Cyclic-amp Radioimmunoassay.
| Device ID | K841478 |
| 510k Number | K841478 |
| Device Name: | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Cyclic Amp |
| Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHO |
| CFR Regulation Number | 862.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-09 |
| Decision Date | 1984-06-14 |