The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Luteinizing Hormone Direct Ria Kit 125/i.
| Device ID | K811024 |
| 510k Number | K811024 |
| Device Name: | LUTEINIZING HORMONE DIRECT RIA KIT 125/I |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | Immunalysis Corporation 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 | 1981-04-15 |
| Decision Date | 1981-05-08 |