The following data is part of a premarket notification filed by Monobind with the FDA for Lh Radioimmunoassay Test System.
| Device ID | K820760 |
| 510k Number | K820760 |
| Device Name: | LH RADIOIMMUNOASSAY TEST SYSTEM |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | MONOBIND 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 | 1982-03-22 |
| Decision Date | 1982-04-16 |