The following data is part of a premarket notification filed by Syva Co. with the FDA for Vista Prolactin Assay.
| Device ID | K926386 |
| 510k Number | K926386 |
| Device Name: | VISTA PROLACTIN ASSAY |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-22 |
| Decision Date | 1993-03-29 |