The following data is part of a premarket notification filed by Syva Co. with the FDA for Vista(r) Human Luteinizing Hormone(hlh) Assay.
| Device ID | K926394 |
| 510k Number | K926394 |
| Device Name: | VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-05-26 |