The following data is part of a premarket notification filed by Immuno Nuclear Corp. with the FDA for Luteinizing Hormone Radioimmunoassay Kit.
| Device ID | K803278 |
| 510k Number | K803278 |
| Device Name: | LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | IMMUNO NUCLEAR CORP. 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 | 1980-12-29 |
| Decision Date | 1981-01-21 |