The following data is part of a premarket notification filed by Endocrine-metabolic Center with the FDA for Radioimmunoassay Luteinizing Hormone.
| Device ID | K811994 |
| 510k Number | K811994 |
| Device Name: | RADIOIMMUNOASSAY LUTEINIZING HORMONE |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | ENDOCRINE-METABOLIC CENTER 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 | 1981-07-14 |
| Decision Date | 1981-07-27 |