The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Luteinizing Hormone Ria Kit.
| Device ID | K833376 |
| 510k Number | K833376 |
| Device Name: | RIANEN LUTEINIZING HORMONE RIA KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-28 |
| Decision Date | 1983-12-20 |