The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Ria Sys. For Human Luteinizing Hormone.
| Device ID | K780367 |
| 510k Number | K780367 |
| Device Name: | RIA SYS. FOR HUMAN LUTEINIZING HORMONE |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | CALBIOCHEM-BEHRING 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 | 1978-03-07 |
| Decision Date | 1978-04-28 |